He manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.Attempts to obtain additional information have been made; however, no more is available.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).Item and lot numbers unknown.
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Investigation results were made available.Event description: it was reported that during surgery the drill fractured and the broken off piece remained in the patient's bone.Review of received data: no medical data relevant to the case has been received.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: document review could not be performed due to unknown product identification.Device purpose: this device is intended for treatment.Conclusion: it was reported that during surgery the drill fractured and the broken off piece remained in the patient's bone.Based on the investigation the reported event cannot be confirmed.No product identification or medical documents like x-rays have been received, therefore no deeper investigation can be performed.Due to significant lack of information a detailed investigation could not be performed, nevertheless based on the given information there is no indication of a nonconformance or complaint out of box (coob).Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.As for zimmer specialists to perform an in-depth analysis it is required to have all necessary information at hand, it was therefore tried several times to receive additional information for this case.The missing information was requested but was not available.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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