SYNTHES MONUMENT 11MM/130 DEG TI CANN TROCH FIXATION NAIL 380MM/LEFT; ROD, FIXATION, INTRAMEDULLARY
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Catalog Number 456.419S |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Non-union Bone Fracture (2369)
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Event Type
Injury
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Manufacturer Narrative
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Additional device product code: hwc.(b)(4).Patient was implanted in 2016 about six to eight months (6-8) ago, exact date was unknown.Device is not expected to be returned for manufacturer review/investigation.Device history record review concluded that (part #: 456.419s, lot#: 7729589 (sterile) - 11mm/130 deg ti cann troch fixation nail 380mm/left - sterile.Quantity 5.No non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Sterility documentation was reviewed and determined to be conforming.)manufacturing location: (b)(4),manufacturing date: july 09, 2014 and expiration date: may 31, 2023.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a patient was originally implanted with a 11.0mm/130 degree titanium trochanteric fixation nail (tfn) left, a 11.0mm titanium helical blade, and an unknown 5.0mm locking screw on an unknown date on about six to eight months (6-8) ago to repair a left femur fracture.On (b)(6) 2016, the patient was returned to the operating room in to remove the devices after it was identified that the patient presented with a non-union.The complained devices were successfully removed and the patient was implanted with a 6 hole dynamic hip screw (dhs) and an unknown number of unknown screws.The surgery was successfully completed without any surgical delay and no adverse events were reported against the patient.This is report 1 of 3 for (b)(4).
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.(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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Search Alerts/Recalls
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