SMITH & NEPHEW, INC. HEALICOIL KNOTLESS RGNST; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Catalog Number 72205135 |
Device Problem
Break (1069)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 10/10/2022 |
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 rotator cuff repair, the healicoil knotless suture anchor snapped when inserting, it broke off inside of the patient, not all the broken pieces were retrieved from the patient, some were retrieved with graspers, but the eyelet stayed in the bone hole.Non-significant delay was reported, and the procedure was finished with a competitor device (swivel lock).No void was left in patient and no further complications were reported.
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Manufacturer Narrative
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Internal complaint reference: (b)(4).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 specifications upon release for distribution.A complaint history review found similar reported events.The instructions for use were 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.A review of the raw material found that the storage requirements for the material are specified, and the material must comply with provided percentage composition specifications as measured by ash test.A clinical review states based on a review of the information provided, not all the broken pieces were retrieved of the healicoil knotless suture anchor broke inside of the patient, some were retrieved with graspers, but the eyelet stayed in the bone hole.No clinically relevant documentation was provided for review.Therefore, a definitive clinical root cause of the reported breakage could not be determined.Therefore, the impact to the patient beyond that which has been reported could not be confirmed nor concluded.Should any additional relevant medical information be provided, this case would be re-assessed.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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Manufacturer Narrative
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Internal complaint reference case (b)(4).The reported device was received for evaluation.There was a relationship found between the device and the reported event.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.The instructions for use were 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.A review of the raw material found that the storage requirements for the material are specified, and the material must comply with provided percentage composition specifications as measured by ash test.A visual inspection of the returned device found that it is not in its original packaging.A small portion of the distal anchor was returned.It has fractured at the proximal end.Based on the condition of the product material found during visual inspection, additional material testing is not required.No clinically relevant documentation was provided for review.Therefore, a definitive clinical root cause of the reported breakage could not be determined.Therefore, the impact to the patient beyond that which has been reported could not be confirmed nor concluded.Should any additional relevant medical information be provided, this case would be re-assessed.The complaint was confirmed, and the root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include excessive force on the device, excessive torque on the device, attempted correction of a damaged device, off-axis insertion, improper preparation of the insertion site, or an inadvertent impact event inconsistent with normal use.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.
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Search Alerts/Recalls
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