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Device Problem
Migration or Expulsion of Device (1395)
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Patient Problems
Failure of Implant (1924); Perforation (2001); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.There was no reported patient involvement associated with the complained event.This report is for one (1) unknown tfna helical blade 105 mm.Part and lot number are not available for reporting.Other number¿udi: part number unknown, udi is unavailable.(therapy date): the initial date of implant is an unknown date approximately six (6) to seven (7) weeks prior to the revision surgery date on (b)(6) 2017.The subject device is not expected to be returned to the synthes manufacturer for evaluation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Without a lot number the device history records review could not be completed.The date of manufacture is unknown.(b)(4).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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The patient underwent a revision procedure on (b)(6) 2017 due a helical blade cut-out.The patient was implanted with a trochanteric fixation nail-advanced (tfna) proximal femoral nailing system to treat a left intertrochanteric hip fracture on an unknown date.On an unknown date, approximately six (6) to seven (7) weeks after the initial surgery, the unknown 105 mm tfna helical blade cut out.The blade was removed intact and replaced with an unknown 75 mm tfna lag screw and then re-locked using a freehand method.There was no damage to the blade.The surgeon decided not to use an aiming arm to implant the lag screw.The doctor chose to not remove or replace the nail.The patient already had a distal locking screw from the initial implant, which remains implanted.However, the surgeon chose to add one more locking screw in the distal aspect of the nail.There was no patient harm or surgical delay.The procedure was completed successfully.The surgeon was happy with the outcome.Concomitant devices reported: nail (quantity # 1), distal locking screw (quantity # 1).This report is for one (1) unknown tfna helical blade 105 mm.This report is 1 of 1 for (b)(4).
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.(b)(6).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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