ARTHROCARE CORP. QFIX 1.8 MINI SUTURE ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Model Number 72290123 |
Device Problem
Failure to Fire (2610)
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Patient Problem
Rupture (2208)
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Event Date 06/23/2022 |
Event Type
Injury
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Event Description
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It was reported that, during a shoulder stabilization of the labrum, two (2) qfix suture anchors did not deploy, the drill hole was prepared properly using the correct 1.8 disposable drill kit.Surgery was resumed, after a non-significant delay, with a back-up device.The surgeon drilled a new hole to use the back-up anchor.A void was left in the patient.No further complications were reported.
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Manufacturer Narrative
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H10: h3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found similar reported events.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.Without the requested clinical information, a thorough medical investigation cannot be rendered.Therefore, the clinical root cause of the reported failure could not be definitively determined.No further risk to the patient is anticipated as a result of the additional bone hole.Since no further harm is anticipated no further clinical assessment is warranted at this time.There was no relationship found between the device and the reported event.The complaint was not confirmed.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
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