ARTHROCARE CORP. 2.8MM Q-FIX ALL SUTURE ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Catalog Number 25-2800 |
Device Problems
Detachment of Device or Device Component (2907); Activation Problem (4042)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/06/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The returned instrument, intended for use in treatment, was returned for evaluation.There was no relationship found between the device and the reported incident.Visual inspection of the returned 2.8mm q-fix all suture anchor shows a deployed instrument.Remaining sutures were visible outside the handle.The implant is detached and a remaining part of the implant is inside the shaft at distal end.There are no visible manufacturing abnormalities found on the device.Functional evaluation could not be performed.The device is a single used device and could not be functional tested.The complaint was not verified.From the information provided, the anchor did not fully deploy.The q fix anchor was pulled out of the bone hole and a remaining part of the implant is inside the shaft at distal end.An exact root cause cannot be determined with confidence; however, factor unrelated to the manufacture or design of the device that could have contributed to the reported event include: bone quality.Drilled bone hole size; poor bone quality or oversized drilled bone hole can result in damage to the device and device failure.The instruction for use were reviewed and were found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
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Event Description
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It was reported that during the surgery, after the site was prepped, the knob was rotating, the anchor did not deploy in the site.5 minutes delay was the procedure.No patient injury was reported.A backup device was used.Results of investigation have concluded that the implant is detached and a remaining part of the implant is inside the shaft at distal end.
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