Device report from synthese reports an event in new zealand as follows: it was reported that during a procedure on (b)(6) 2023, the bone reduction forcep broke during fracture reduction.The forcep and broken arm were removed from the surgical field, and another instrument was used to continue the surgery.There was no delay, and the procedure was completed successfully with no further complication.There was no patient consequence.The fragments generated were easily removed without additional intervention.This report involves one unk - guides/sleeves/aiming: aiming arm.This is report 2 of 2 for (b)(4).
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Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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.This report is for an unknown guides/sleeves/aiming: aiming arm /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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