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Model Number 04.641.002 |
Device Problem
Device Slipped (1584)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/03/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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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Event Description
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Device report from synthes (b)(6) reports an event as follows: it was reported that on (b)(6) 2019, the patient underwent a spine procedure.During the procedure, the nut of a rib hook would not lock with the torque limiting wrench and would just keep spinning.The surgeon tightened another rib hook to verify the torque limiting device was not the issue.The surgeon then removed the malfunctioning rib hook and replaced it with a different identical hook.There was a fifteen (15) minutes surgical delay.The procedure was successfully completed with no patient consequence.Concomitant device reported: torque limiting wrench (part/lot unknown, quantity 1); locking caps (part/lot unknown, quantity unknown).This report is for a rib hook.This is report 1 of 1 for (b)(4).
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Manufacturer Narrative
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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.H11: d10: complainant part is not expected to be returned for manufacturer review/investigation.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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Search Alerts/Recalls
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