Catalog Number 6541-4-811 |
Device Problems
Device Reprocessing Problem (1091); Crack (1135); Degraded (1153); Peeled/Delaminated (1454); Material Integrity Problem (2978)
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Patient Problems
No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
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Event Date 06/16/2016 |
Event Type
malfunction
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Manufacturer Narrative
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When completed, the investigation results will be submitted in a supplemental report.
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Event Description
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Rubber on handles and impactors are cracked and peeling.Hospital has concerns that containments were being trapped in cracks and not being cleaned well enough.
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Manufacturer Narrative
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An event regarding wear involving a femoral impactor was reported.The event was confirmed.A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there was one other event for the reported lot.The device was returned in used condition.The bottom portion of the device shows signs of wear with pieces chipped off.There are also scratches and abrasions conclusion: the device was discovered during inspection; there was no surgical procedure associated with the reported event.This event meets the definition of preventive maintenance; no further investigation is required at this time.
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Event Description
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Rubber on handles and impactors are cracked and peeling.Hospital has concerns that containments were being trapped in cracks and not being cleaned well enough.
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Search Alerts/Recalls
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