Device report from depuy synthes reports an event in japan as follows: it was reported ton (b)(6) 2023, the patient underwent removal surgery with handle with quick coupling.The patient was young and had hard bones, and the product in question was too thin so the surgeon could not turn it with any strength.The surgeon was able to remove screws using another company's product with a thicker handle.The surgeon requested that a thick handle be added to the tcp extraction set.The surgery was completed successfully without any surgical delay.No further information is available.This report is for one (1) handle with quick coupling, small.This is report 1 of 2 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.H10 additional narrative: 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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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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