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 expected to be returned for manufacturer review/investigation, but has yet to be received.H3, h6: 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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It was reported that on (b)(6) 2024 the surgeon was implanting the two fibulinks in question.While tensioning down the fibulinks, the suture snapped away from the link.The surgeon then used the same cap and tried to tighten down the second fibulink, but that one snapped as well.The surgeon commented that the torque limiting feature of the tensioning cap was not working, however when they tested it afterwards it seemed to work properly.The procedure was completed successfully with a surgical delay of 10 minutes.There was no reported adverse patient impact.No further information is available.This report is for a fibulink(r) syndesmosis repair kit/ss.This is report 1 of 2 for (b)(4).
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