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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Bone Fracture(s) (1870)
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Event Type
Injury
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Manufacturer Narrative
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510k: this report is for an unknown plate/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that on (b)(6) 2020, patient underwent a hardware removal procedure due to a new tibial fracture, distal to osteotomy and tomofix construct.The surgeon removed the tomofix and corresponding screws and inserted an ex tibial nail for treatment of osteotomy sight and new fracture.Procedure was successfully completed and there was no surgical delay.Patient status was unknown.This complaint involves eight (8) devices.This is report 1 of 8 for (b)(4).
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Manufacturer Narrative
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Product complaint #(b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.E1: initial reporter hospital account: address, state and zip code provided for reporting.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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