SMITH & NEPHEW, INC. BIOSURE PK 8 X 25MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Model Number 72202267 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/19/2021 |
Event Type
malfunction
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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 before an acl procedure, the biosure sterilization package paper had three holes on it.A backup device was available to complete the procedure.No significant delay or patient injuries reported.
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Manufacturer Narrative
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Internal complaint reference: (b)(4).H3, h6: the device, intended for use in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.An analysis of the customer provided image shows the sterile pouch and label.There are no perforations in the image field.A visual inspection found that the device was returned in original packaging.The sterile pouch was torn open and no evidence of punctures were found.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 concluded this was an isolated event.A review of the print specifications found that the pouches should be visually inspected to be free of nicked or frayed edges.The pouches must be clean and free of foreign particles.The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.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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