SMITH & NEPHEW, INC. FOOTPRINT ULTRA PK SUTURE ANCHOR 5.5; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Model Number 72202902 |
Device Problem
Break (1069)
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Patient Problem
Rupture (2208)
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Event Date 11/16/2022 |
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 an arthroscopy, the anchor of the footprint suture broke while tapping into the bone.All broken pieces were successfully removed with the help of a grasper.Surgery was completed after a non-significant delay, using a back-up device in an additional bone hole.No further complications were reported.
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Manufacturer Narrative
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H10: h3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.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 material specifications found that the raw material strength requirements and storage requirements specified and each lot be must be accompanied by a material certificate of analysis.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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