Additional:h2, h6.Correction: b4, g4, g7, h10.No trend considering the following event is identified: instrument fracture.Device history records (dhr): as no lot numbers were provided for the device, the device history records could not be reviewed.An e-mail requesting missing device data information was sent to the complainant, however no additional information is currently available.At zimmer gmbh all medical devices prior release to market undergo several quality inspections as defined in our quality procedures.Our quality inspection- and deviation procedures ensure that only products fulfilling the specification are sold.These procedures are part of the overall quality management system at zimmer gmbh and get regularly audited by our notified body, competent authorities and internal and external auditors.Thus, for all products sold to the market can be assumed having a complete and correct dhr.Event summary: it is reported that during a shoulder arthroplasty implanting a as revision stem (size 7 x 190), tm baseplate (15mm post) and glenosphere (36) the green 36 +0 trial bearing was used to ensure the correct bearing was opened and implanted.When removing the trial from the definitive stem (which had been cemented in) fragments of the plastic bearing trial fractured from the trial and had to be removed from the patient.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received.Devices analysis: no product was returned to zimmer biomet for in-depth analysis; according to the information received the device location is unknown.Root cause analysis: root cause determination using rmw: - instrument breaks, deforms, diverge or parts remain in wound due to inadequate design for intended performance not possible -> a systematic issue with design and/or material properties would have been detected as part of the issue evaluation assessment.- instrument breaks, deforms, diverge or parts remain in wound due to mechanical properties of material insufficient => possible, raw material certificate could not be reviewed, therefore cannot be excluded.- instrument cannot be used with the mating instrument or mating implant as intended due to failure of instrument mating condition => possible, if the instrument is not maintained well over time it can fail.- fracture of instrument due to degradation of material due to cleaning and sterilization => possible, if the instrument is not maintained well over time it can fail.- wear particles can get into the wound can cause foreign body reaction due to excessive wear particles generated by instrument interfaces during use => possible, deterioration in function as a result of repeated use could lead to failure.- instrument breaks, deforms, diverge or parts remain in wound due to inadequate design for intended performance not possible -> a systematic issue with design and/or material properties would have been detected as part of the issue evaluation assessment.- instrument breaks, deforms, diverge or parts remain in wound due to surgeon or staff unfamiliar with instrument usage and handling => possible, deterioration in function as a result of repeated use could lead to failure.- damaged instruments, implants, body or wrong operational step due to surgeon or staff unfamiliar with instrument usage and handling => possible, utilization by unqualified and/or untrained individuals could lead to failure.- instrument breaks or deforms due to off-label / abnormal-use => possible, abnormal use could lead to failure.Conclusion summary: according to the event the provisional insert fractured while being removed from the stem.Product was not received for the investigation.No photos were available, neither the lot number of the instrument.Possible reasons of the failure include insufficient mechanical properties of material, degradation of material due to cleaning and sterilization, deterioration in function as a result of repeated use, utilization by unqualified and/or untrained individuals and abnormal use.Based on the given information and the results of the investigation, the complaint could not be confirmed as the alleged failure could not be identified or reproduced.The need for corrective measures is not indicated and zimmer biomet considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).
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