Device report from synthes reports an event in canada as follows: it was reported on september 6, 2022, that 2.0mm drill tip wire became stuck in cannulation of compression/distraction device.Surgeon was able to remove the wire with pliers but cannulation was unusable.Case continued with only using wires in 3 remaining holes of compression/distraction device.On inspection after the case the wires in the set all looked heavily used and blunt/bent so were discarded.Ulna shortening osteotomy.Surgery was delayed for 5 minutes and more.Procedure was successfully completed.No fragments were generated.Patient status/ outcome / consequences :no.This report is for one (1)2.0mm kirschner wire w/ drill tip/100mm.This is report 11 of 11 for complaint (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional product code: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.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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