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Catalog Number 22-4038 |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Information (3190)
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Event Date 06/03/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(6).
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Event Description
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It was reported that during a right shoulder stabilization, surgeon then attempted to use a firstpass mini, but it was difficult to pass the needle through the tissue so doctor moved to a firstpass standard.At the end doctor required to use a champion passer (stryker).It is unknown if there was a delay in the procedure, no further complications were reported.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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H10 h3, h6: the device reported, used in treatment, was not returned for evaluation.A relationship between the product and reported incident cannot be established.A review of manufacturing records for the reported lot number 2032363 found no non-conformances or anomalies during manufacturing process related to the reported event.A complaint history review found related failures; this failure mode will be trended to assess for any necessary corrective actions.Review of the product instructions for use found adequate warnings and precautions to prevent damage to the device during use.Risk management documents were reviewed finding no additional risks that require to be added to the reference document.A visual inspection and functional evaluation cannot be performed and customer´s complaint cannot be confirmed.Potential factors unrelated to the design or manufacture of the device that may lead to the failure reported include, but are not limited to: excessive force applied to device shaft.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.
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Search Alerts/Recalls
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