STRYKER TRAUMA KIEL GUIDE WIRE, BALL-TIPPED, STERILE T2 TIBIA Ø3X800 MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Model Number 1806-0080S |
Device Problem
Contamination /Decontamination Problem (2895)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/19/2019 |
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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It was reported, during an in-coming inspection at distribution, it was found that there was a foreign material (hair) in blister package.This event was found on 1 of 90 units with lot# k0ac0b4.
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Event Description
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It was reported, during an in-coming inspection at distribution, it was found that there was a foreign material (hair) in blister package.This event was found on (b)(4) units with lot#k0ac0b4.
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Manufacturer Narrative
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The reported event could be confirmed.During the visual inspection of the item received a hair was found out of the sterile barrier between the clear tube and the pouch within the secondary packaging.According to details received it was detected during ¿in-coming inspection¿.A review of the dhr revealed no discrepancies.Sealing seams and original packaging are still intact.Thus, it has been determined 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.
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Search Alerts/Recalls
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