ARTHROCARE CORP. 1.8MM Q-FIX ALL SUTURE ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Catalog Number 25-1800 |
Device Problem
Positioning Problem (3009)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/08/2020 |
Event Type
Injury
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Event Description
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It was reported that during surgery, the q-fix suture anchor did not seat in bone properly, it was pulled out with tension.The malfunction occurred again with the second q-fix anchor.The procedure was completed with a backup device from smith and nephew with no delay.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 found no non-conformance's or anomalies during manufacturing process related to the reported event.A complaint history review found related failures.Review of the product instructions for use (ifu) 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: (1) excessive force (2) misalignment of inserter and implant during and after insertion.No containment or corrective actions are recommended at this time.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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Manufacturer Narrative
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The reported device, used in treatment, was returned for evaluation.There was no relationship found between the reported incident and the returned device.A review of the device history records for the reported lot number 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 an repeated event.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found that excessive force, incomplete insertion or poor bone quality may result in implant pullout or suture breakage.Visual evaluation shows the device returned deployed.The shaft is loose.No manufacturing discrepancies observed.The returned device is a single use and could not be functional tested.The complaint was not confirmed.Factors that could have contributed to the reported event include: excessive force; misalignment of inserter and implant during and after insertion; bone quality.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
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