The manufacturer received photographs which will be reviewed as part of ongoing investigation.The complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch 3500a will be submitted.The lot number of the device was received.The device history records will be reviewed during investigation.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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Investigation results were made available.Review of event description: it was reported that the screw head is worn.A patient was not involved.Review of received data: no patient involvement, therefore no medical data.Due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Product evaluation: visual examination: the screw (ref.01.00109.809) was received for examination.The screw has scratches on the outer surface and a few worn threads.The head of the screw has a worn hexagonal female thread.Review of product documentation: device purpose: this device is intended for treatment.Dhr review: the screw was manufactured in february 2007.The manufacturing documents were reviewed.Due to ensured functionality, there was a special clearance for machining marks found in the hexagonal female thread.Conclusion: it was reported that the screw head is worn.A patient was not involved.The scratches noted on the screw indicate that the screw is worn, possibly from repeated use, cleaning, and sterilization over a long period of time.The hexagonal female thread was found worn, possibly deriving from over-torquing.Since the device was manufactured in 2007, and based on the multiple signs of wear from usage, neither a nonconformance nor a complaint out of box (coob) was identified.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).
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