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Model Number 72200903 |
Device Problem
Delivered as Unsterile Product (1421)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/10/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that, during shoulder rotator cuff repair surgery, while opening the threaded cannula packages, the product had a foreign body inside package.The malfunction was solved with a delay shorter than 30 minutes and no patient harm using a back up device.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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The reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.An analysis of the customer provided images confirmed the part and batch numbers.There appeared to be a dark fiber of medium thickness within the packaging.A visual inspection revealed that two unopened packages of the same batch number were returned.In the corner of the first package, a thick, dark blue fiber could be seen.In the corner of the second package another dark fiber was found.There were not any packaging punctures or unsealed areas.A review of the device records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.A review of the drawing found that packages must not contain particulates, debris, hair, or other foreign materials.The complaint was confirmed and the root cause was associated with manufacturing.Although every effort is made to control particulate in the controlled clean room, it is not possible to completely eliminate foreign matter in the area due to the human element.A correction in the form of a complaint notification has been issued to manufacturing management to mitigate future recurrences.
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Search Alerts/Recalls
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