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Device Problem
Failure to Align (2522)
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Patient Problem
No Code Available (3191)
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Event Date 01/01/2019 |
Event Type
Injury
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Manufacturer Narrative
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This report is for an unknown unk - nails: tfna /unknown lot number.Without the specific part number, the udi number and 510k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4): the reported event required medical/surgical intervention to preclude permanent damage to a body structure and medical device removal.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.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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It was reported that on an unknown date, patient underwent removal because it was discovered during follow-up visit that the unknown helical blade did not go through the unknown nail.An unknown trochanteric fixation nail advance (tfna) was implanted on an unknown date.During surgery the cannulated stepped drill bit broke off.There was a twenty (20) minutes surgical delay.Procedure outcome and patient status are unknown.Concomitant device reported: unknown screws (part #: unknown, lot #: unknown, quantity #: unknown).This complaint involves two (2) devices.This report is for one (1) unk - nails: tfna.This report is 2 of 2 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.B3: exact date of event is unknown.H3, h4, h6: 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.G4: the incorrect g4 date was inadvertently utilized in initial medwatch.The correct date is august 8, 2019.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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Updated event description: it was reported that on (b)(6), 2019, the patient underwent removal proceudre because during follow-up visit it was discovered that the unknown helical blade did not go through the unknown nail.An unknown trochanteric fixation nail advance (tfna) was implanted on an unknown date in june.The tfna nail remained in the femur and a new helical blade was placed.During revision surgery the cannulated stepped drill bit broke off.There was a twenty (20) minutes surgical delay.Procedure was successfully completed.Patient outcome was unknown.This report captures the post-op event of removal of the tfna, while related complaint (b)(4) captures the intra-op event of drill bit breakage.Concomitant device reported: unknown screws (part #: unknown, lot #: unknown, quantity #: unknown).
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Search Alerts/Recalls
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