OBERDORF SYNTHES PRODUKTIONS GMBH 14MM/130 DEG TI CANN TFNA 460MM/LEFT-STERILE; ROD,FIXATION,INTRAMEDULLARY
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Catalog Number 04.037.467S |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Device is not expected to be returned for manufacturer review/investigation.(b)(4).Product was not returned.Device history records review could not be completed without lot number.Based on the information available, it has been determined that no corrective and 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)(4) reports an event in (b)(6) as follows: it was reported that on an unknown date, the surgeon noted an x-ray of a broken smith and nephew nail and an unhealed proximal femur.Two (2)trochanteric fixation nail-advanced (tfna) with augmentation was planned and order was made.The revision surgery was scheduled for (b)(6) 2018.Prior to revision, while checking if everything was there, it was noted that the received tfna nails were not received.As a result, revision surgery was reschedule to (b)(6) 2018 while inquiries were made about missing nails.Nails were not received by (b)(6) 2018 and the decision was made to go ahead with the surgery.The surgeon had to use a shorter nail because the nails could not be delivered before surgery.As the surgery progressed, it was realized that the optimal nail length and diameter was one of the ones that had not received.However, in the end the surgeon was happy with the result.Patient outcome is unknown.This report is for one (1) tfna nail.This is report 2 of 2 for (b)(4).
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Search Alerts/Recalls
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