The manufacturer did not receive x-rays but received other source documents for review.The manufacturer did not receive the device for investigation.The device history records were reviewed and found to be conforming.Attempts to obtain additional information have been made; however, no more is available.The implantation and explantation dates are left empty as the device involved in this complaint is an instrument.Hence, no expiration date is captured, for the same reason.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available, an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).
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This follow-up report is being submitted to relay corrected and additional information.Event summary: it was reported that during surgery, the threads are chipped.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.No other case-relevant documents received.Devices analysis: the product has not been returned for an investigation.However, pictures have been received.There is a dent in the threads of the threaded tip.No further conspicuousness detected.Review of product documentation: this device is intended for treatment.Conclusion summary: it was reported that during surgery, the threads are chipped.Based on the investigation the reported event can be confirmed.The investigation results did not identify a non-conformance or a complaint out of box (coob).The observed damage indicates that the part might have experienced an excessively high force, resulting in the dent at the threads.However, an exact root cause for the instrument damage could not be determined.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).
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