It was reported that the surgeon planned to remove a patella plate on (b)(6)2022.The reason for removal was that the patient was experiencing pain when kneeling.The hardware had been placed approximately a year ago.The hardware was successfully removed.The removal was very difficult because of the angle of the inferior screws, and one of the screws cold welded to the plate.The plate had to be cut around the screws, and the screw removal set was used to remove the screw.No further information is available.This report involves one unk - screws: 2.7 mm va locking.This is report 3 of 11 for (b)(4).
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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.510k: this report is for an unknown screws: 2.7 mm va locking/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.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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