(b)(4).Report source, foreign - event occurred in (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Post code: (b)(6).Occupation: theatre manager.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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(b)(4).This final report is being submitted to relay additional information.G3: report source, foreign - event occurred (b)(6).Products have been returned to biomet uk ltd for evaluation and forwarded to a research engineer for investigation.An oxford spherical cutter was returned due to fracture after a maximum time in use of 9 years and 1 month.The cutter was returned assembled, with the fragment of the shaft assembly that the standard drill attaches to stuck to the rest of the shaft assembly, albeit with a gap.The instrument appears to be in overall good condition otherwise.The fracture surfaces on the received components suggest that the fracture occurred suddenly, as opposed to fracture due to fatigue.The relevant manufacturing history records (mhrs) for the oxford spherical cutter confirm that the hardness of the centre shaft assembly was in accordance with its specification.The manufacturing history records (mhrs) related to the involved product has been reviewed and does not show any non-conformity, rejection or concession that could be related to the reported event.A review of the complaint database over the last 3 years has found 2 similar complaints reported with item 32-420330.No similar complaints were found for the combination, item 32-420330 and lot zb090122.No corrective actions have been taken at this time since no design or manufacturing issues have been identified.The available mhr reviews indicates that the product was most likely conforming to design specification when it left zimmer biomet control, however it is not possible to confirm the root cause of the fracture of the oxford spherical cutter with the information available.Risk assessment: risk management report documents the estimated residual risk associated with the device within the reported event.Failure analysis report concludes: an oxford spherical cutter was returned due to fracture after being used once in a maximum period of 9 years and 1 month.The fracture surface on the received component suggests that the fracture occurred suddenly, as opposed to fracture due to fatigue.The reported event did not cause a significant delay to the surgery or any other complication.The ultimate reason for the fracture of the oxford spherical cutter cannot be determined with the information available at the time of writing this report.The reported event states instrument fracture.The details of the reported event do not allege that there was any patient harm or delay to surgery.Therefore, the severity is considered s-1 (negligible) as per definitions within the severity table in the rmr.The reported event is considered to be within the severity of the rmr.No corrective or preventive actions are deemed necessary at this time.If further information regarding the root cause of the reported event is provided, risk should be re-assessed.
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