SMITH & NEPHEW, INC. MICRORAPTOR KNOTLESS SA PEEK; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Model Number 72205021 |
Device Problems
Break (1069); Fracture (1260); Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/23/2023 |
Event Type
malfunction
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Event Description
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It was reported that during the execution of an arthroscopy procedure, when opening the microraptor knotless peek implant, the proximal part of the anchor was missing, then, it was noticed that the anchor was badly assembled.In addition, the anchor in its distal part was somewhat fractured.The procedure was successfully completed with a non-significant surgical delay using a back-up device.No further complications were reported.
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Manufacturer Narrative
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Internal complaint reference: case-(b)(4).
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Manufacturer Narrative
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Internal complaint reference (b)(4).H10.H3, h6: the reported device was received for evaluation.A visual inspection of the returned device found that it has been opened.The proximal anchor was off the insertion device and the device had been actuated (the torque driver is in the post insertion position) and the distal anchor was screwed onto the distal end of the insertion device.There is no damage to the anchors when viewed under magnification.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.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 packaging process found that the operator should inspect device/trays for integrity and particulate before loading device into pouch.A review of the anchor material specifications found that the raw material strength requirements and storage requirements are specified and each lot must be accompanied by a material certificate of analysis.The root cause could not be determined since the reported malfunction could not be duplicated during the investigation.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.
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Search Alerts/Recalls
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