STRYKER TRAUMA KIEL GUIDE WIRE, SMOOTH-TIPPED, STERILE T2 HUMERUS Ø2,2X800 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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Model Number 1806-0093S |
Device Problems
Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)
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Patient Problem
No Patient Involvement (2645)
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Event Date 04/20/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Once the investigation has been completed, any additional information will be reported in a supplemental report.
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Event Description
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In in-coming inspection at distribution, it was found that there was a foreign material (hair) in blister.No patient involvement, adverse consequences, delay or medical intervention.
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Manufacturer Narrative
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The returned device matched the report and the complaint failure mode was confirmed.Referring to product inquiry the guide wire, smooth-tipped, sterile t2 humerus ø2,2x800 mm [packaging] is stated to be the primary product.No further associated products were reported.A review of the dhr revealed no discrepancies.Sealing seams and original packaging are still intact.Thus, the pollution must have occurred during the packaging process, which was not detected during inspection.Based on the above facts the root cause of the reported event is related to an inadequate packaging process / insufficient inspection specification.The found foreign material [hair] has to be classified as a non-conformance.Ncr # (b)(4) was triggered for further root cause investigation.
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Event Description
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In in-coming inspection at distribution, it was found that there was a foreign material (hair) in blister.No patient involvement, adverse consequences, delay or medical intervention.
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Search Alerts/Recalls
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