[Handling of retrieved implants in orthopedic surgery : Results of a survey within the framework of the EndoCert initiative]. / Bestandsaufnahme zum Umgang mit ausgebauten Implantaten in der orthopädischen Chirurgie : Ergebnisse einer Umfrage im Rahmen der EndoCert-Initiative.

BACKGROUND: Although investigations of retrieved medical implants can provide valuable information about the cause of the revision, there is a lack of information, which could be avoided by consequent failure analyses. In the framework of the EndoCert certification system it is obligatory to record and report incidents. OBJECTIVES: The present work examines how the willingness to report has developed in certified arthroplasty centers and which method of handling retrievals is preferred and actually used. MATERIALS AND METHODS: On the basis of a questionnaire for handling retrievals, all 508 arthroplasty centers that were certified till June 1, 2016, were included (return rate = 97.2%). RESULTS: A total of 93.3% of the centers have established an algorithm for handling of retrievals and 83.0% of the centers prefer to hand out the retrieval to the patient, while only 25.7% wish to store it in the center for research purposes. In the case of a potential incident as the cause of revision, centers prefer to forward the retrieval to damage analysis, whereby the centers act in different ways, depending on the case. An implant fracture is, e.g., considered a reportable event in most cases without temporal limitation. On the other hand, breakage or failure of surgical instruments is considered not to be reported in the case of more than half of the centers. In 2014 and 2015, approximately 71% of EPZs reported no incidents. CONCLUSIONS: According to our survey, many certified arthroplasty centers are sensitized to careful handling of retrievals. The treatment of the explanted components is conducted in different ways. The assessment of whether an incident is to be reported shows large differences. In view of the relatively high number of revision surgeries, the number of reports to the authorities appears to be low.

[Reportable incidents with surgical instruments in orthopedic surgery]. / Meldepflichtige Vorkommnisse mit Operationsinstrumenten in der Orthopädischen Chirurgie.

BACKGROUND: Breakage of instruments in orthopedic surgery is rarely reported but the consequences can be serious for both patients and surgeons. The medical device directive classifies instruments, such as drills and saws into risk class 1 with low approval requirements. Also the number of applications of reusable instruments is not currently limited. OBJECTIVES: The aim of this study was determine to what extent instrument failure can lead to reportable incidents and how these incidents should be processed. METHODS: The study involved an evaluation of clinical cases from our institution with a selective literature review and discussion of the medical device directive. RESULTS: The experience in our clinic showed that especially breakage of rasps in total hip and knee replacement surgery is associated with a major time extension of the operational procedure, a wider surgical access opening as well as complicated procedures to recover the fragments from the incident site. In individual cases a fenestration of the bone had to be conducted in order to collect the broken piece of the rasp. In one case a revision hip stem had to be used instead of the planned primary stem in order to bridge the fenestration site. CONCLUSION: Such consequences of instrument failure were considered to be a reportable incident. A thorough documentation as well as incident reporting to the manufacturer and the Federal authorities are required for a sufficient processing and risk assessment of the incident.

[Recommendations for documentation of incidents with medical devices in orthopaedic surgery]. / Empfehlungen zur Dokumentation von Vorkommnissen mit Medizinprodukten in der Orthopädischen Chirurgie.

The growing number of revisions in orthopaedic surgery as well as the multifactorial reasons for implant failure give cause for taking a closer look at the clinical documentation of adverse events. Based on our long-term experience it is our goal to present recommendations for an adequate documentation and filing. In the framework of the introduction of a quality management system (ISO 9001:2008) in our hospital, a process was developed for reportable incidents with medical devices regulating adequate documentation. Therefore, specific forms were developed. The retrievals are stored for subsequent damage analyses and are available for possible legal claims and tracking. A file should be opened for each reportable incident containing information about the event, a copy of the obligatory BfArM report, surgery report, medical device labels, radiographs and photographs. Declarations of agreement as well as handover certificates should be maintained in order to keep record of the retrievals. In order to assure consistent documentation, we recommend use of specific forms as presented in this paper. Identification of risk factors for implant failure and a long-term reduction of damage cases will only be possible under consequent incident reporting and responsible documentation of adverse events. Processing of cases of damage is accelerated and simplified by the presented recommendations and forms. Together with the newly established joint replacement registry, a higher quality of patient treatment and implant safety should be obtained.