Model Number N/A |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problem
Tissue Damage (2104)
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Event Date 02/02/2016 |
Event Type
Injury
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Manufacturer Narrative
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Current information is insufficient to permit a conclusion as to the cause of the event.The product identification necessary to review manufacturing history was not provided.The following sections could not be completed with the limited information provided.Expiration date - unknown; manufacture date ¿ unknown.There are warnings in the package insert that state that this type of event can occur.This report is number 1 of 2 mdrs filed for the same event (reference 1825034-2016-00774 / 00775).
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Event Description
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It was reported during a hip fracture nail procedure on (b)(6) 2016, a lag screw interfered with the nail hole.The surgeon turned the set-screw but the lag screw could not be inserted into the nail hole.Another lag screw was used but it also interfered with the hole.Subsequently, another nail and the other lag screw were used to complete the procedure.Additional holes were drilled to complete the procedure.
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Manufacturer Narrative
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This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.
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Manufacturer Narrative
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This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.(b)(4).Examination of returned device found no evidence of product non-conformance.Visual inspection of the nail and lag screws shows some scratches on the inside of the hip nail where the lag screw inserts with some corresponding scratches on the lag screws.A conclusive root cause of the event could not be determined.
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Manufacturer Narrative
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This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.
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Search Alerts/Recalls
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