Concomitant medical product: cortical bone screw, 4x32mm, item# 47248613240; lot# 2999923.The manufacturer did not receive x-rays for review.Other source documents were received and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.The device history records were reviewed and found to be conforming.Additional information has been requested and is currently not 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).
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Investigation results were made available.Review of event description: it was reported that operation was performed with ann nail system on nov 17, 2020.After the proximal screws were inserted into the nail, the surgeon tried to lock the corelock system, but it didn't move and stuck inside the nail.The operation was finished without fixing the screws by the corelock.There is concern that the screws will back out in the future.Review of received data: no medical data relevant to the case has been received.Due diligence: further due diligence to support the conclusion was completed and documented.However, no additional information could be obtained.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.The products remain implanted.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the compatibility check was performed and showed that the product combination was approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Conclusion: it was reported that operation was performed with ann nail system on nov 17, 2020.After the proximal screws were inserted into the nail, the surgeon tried to lock the corelock system, but it didn't move and stuck inside the nail.The operation was finished without fixing the screws by the corelock.There is concern that the screws will back out in the future.Based on the investigation the reported event cannot be confirmed.As no surgical report has been received, the events leading to the jamming of the corelock cannot be recreated.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a 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.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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