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(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Concomitant medical products: the product has been requested to be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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It was reported that during the surgery, while impacting the tibial implant, the distal tip of the impactor broke into the patient body.The piece was removed from the patient body.There were no remaining piece left in the patients body.The were no consequences on the patients body/health.
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(b)(4).This final report is being submitted to relay additional information.Complaint summary: products have been returned to biomet uk ltd for evaluation and forwarded to the complaints processing unit for investigation.The complaint states: it was reported that during the surgery, while impacting the tibial implant, the distal tip of the impactor broke into the patient body.The piece was removed from the patient body.There were no remaining piece into the patient body.The were no consequences on the patient body/health.Event occurred during surgery.No health consequences or impact.Inspection of returned product confirmed the reported event, the posterior hook which is used to hold the tibial tray during insertion and impaction, has fractured from the main body of the instrument.Visual inspection confirmed the reported event, the posterior hook which is used to hold the tibial tray during insertion and impaction, has fractured from the main body of the instrument.The instrument shows signs of wear & tear (indentations and heavy scratches) which is in line with repeated use and time in field (approximately 10 years).Dimensional check was not carried out as dimensional non-conformance does not have any impact on the reported event.No assembly checks were carried out as returned product was damaged.Review of material certificates from zapp and sandmeyer steel confirm that the material is conforming to standards and specification prior to shipment to zb.A review of the manufacturing history records shows that there were no recorded non-conformances during the production of the instrument and the certificate of conformance confirms that the device was processed and verified in line with the specification and quality characteristics as defined by zimmer biomet.A review of the complaint database over the last 3 years has found 30 similar complaints reported with the item (b)(4) and there are 30 complaints of similar issue for which (b)(4) had been raised initially to investigate the issue and determine no breach against remediated risk file however, (b)(4) was initiated to assess whether additional complaints impacted the occurrence rate in risk file.The outcome of (b)(4) states that capa/scar was not recommended.All occurrences are within the acceptable level determined by the latest version of the risk matrix for this device.This issue is also being monitored by complaint trending.The ifu provided with the compatible implants states: intra-operative fracture or breaking of instruments has been reported.Surgical instruments are subject to wear with normal usage.Instruments, which have experienced extensive use or excessive force, are susceptible to fracture.Surgical instruments should only be used for their intended purpose.Biomet recommends that all instruments be regularly inspected for wear and disfigurement, and prior to surgery.The surgical technique for cementless implantation advises that the device is to be impacted by the toffee mallet and that the device is to release the tibial tray before the tray is fully seated within the patient¿s bone.The reusable instrument lifespan manual instructs to look for fractures and surface damage during reprocessing.Instructions state, as per reusable instrument lifespan manual: while loading instruments into their respective instrument cases after cleaning and prior to sterilization, reference the manual and follow the instructions below.1.Instruments should be inspected for completeness and function.2.Inspection includes: a.Checking instruments that form part of a larger assembly or assemble with mating components.B.Inspecting for all forms of wear outlined in this manual.3.Results of assembly, actuation, and extent of all forms of wear should be considered in determining whether an instrument is suitable for use.4.If the reusable instrument is determined no longer suitable for use or if the suitability for use is still in question after inspecting the instrument and referencing the reusable instrument lifespan manual, initiate the process to return the instrument(s) to the manufacturer.Fractures may occur in the oxford cementless tibial inserter as a result of wear and/or fatigue failure under mis-use conditions.Under normal loading the inserter is not expected to be subject to loads that would cause the type of fracture seen in the complaint received.However, the information provided in the complaint does not provide enough evidence to categorically state that the force applied in this direction alone could cause the observed breakage.The root cause of the reported event could not be determined.The fracture could be ascribed to expected wear and tear over time, over impaction of the instrument, over/under-tightening of the instrument against tibial trays, sub-optimal use during surgery, or a combination of all these factors.The memorandum from the development team details possible misuse scenarios in which the posterior tab may be subjected to loading that could have caused the reported fracture.These scenarios are: 1.Use of the inserter to fully impact the device, resulting in posterior tab becoming trapped between the bone and implant.2.Use of excessive force when tightening the thumb wheel may lead to high anterior-posterior loading on the posterior tab.3.Use of the inserter to remove a partially or fully seated implant, by impacting an internal surface in a direction up and away from the patient; 180deg.Opposite to the impaction required for the insertion.The hazard and reported harm are covered by the risk file and the severity/occurrence and the risk scores are within acceptable limits.The overall risk is considered to be low.Capa: no corrective or preventive action required at this time.The investigation is completed based on current available information.If any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.
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It was reported that during the surgery, while impacting the tibial implant, the distal tip of the impactor broke into the patient body.The piece was removed from the patient body.There were no remaining piece left in the patients body.The were no consequences on the patients body/health.
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