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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d2b: additional product code: hwc d9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j sales representative.H3, h4, h6: 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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It was reported that plates were implanted in the patient, the locking screws did not lock in 1-2 holes of the pl and medial plates so those plate holes were not filled.The surgeon initially used a va guide but later used a non locking drill guide.Unsure if it¿s because he used a metaphyseal screw first to suck the plate down, and then changed for a val.We¿ve had issues with this plate not locking, surgeon did not want patient to be charged.While inserting cortical screws and a 7.3 cannulated for the olecranon osteotomy he also complained of the screwdriver heads being stripped or warped.There were no patient outcomes reported.This report is for one (1) 2.7/3.5 va pstlt dhp-lat supt 4h/l/88-md this is report 2 of 7 for complaint (b)(4).
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