Model Number N/A |
Device Problems
Bent (1059); Unable to Obtain Readings (1516); Sticking (1597); Device Operates Differently Than Expected (2913)
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Patient Problem
No Code Available (3191)
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Event Date 06/29/2015 |
Event Type
Injury
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Event Description
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It was reported that patient underwent a hand fracture procedure on (b)(6) 2015.During the procedure, the drill bit bent.Another drill bit was attempted but cold welded to the guide.It was noted the depth gauge could not get a reading as it was sticking when hooked into the cortex.A smaller drill bit and another depth gauge was utilized to complete the procedure.Additional holes had to be drilled in the patient.
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Manufacturer Narrative
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The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.
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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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Examination of returned device found no evidence of product non-conformance.Evaluation of the returned device found the fast guide component is cold welded to the drill bit and is unable to be removed for dimensional analysis.It was noticed that this drill bit is also bent which likely was caused by the surgeon drilling at an angle causing friction against the inside diameter of the fast guide leading to the cold welding of the two parts.This report is number 1 of 2 mdrs filed for the same event (reference 1825034-2015-03462 & 04124).
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Search Alerts/Recalls
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