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Model Number SUTURE ANCHOR, PEEK PUSHLOCK |
Device Problems
Contamination (1120); Packaging Problem (3007)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/20/2022 |
Event Type
malfunction
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Event Description
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It was reported that the packaging was covered with bloodstains.There was no harm for patient, operator or third party reported.This was noticed during inspection.No further information received.
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
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Manufacturer Narrative
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The complaint is confirmed based on the customer provided photo, which displays the boxes with red stains.However, without return of the device for physical evaluation, the cause remains undetermined.No change in harm was identified.
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Search Alerts/Recalls
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