MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE PK 8 X 25MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72202267
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• Brand Name: BIOSURE PK 8 X 25MM
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11965487
• Report Number: 1219602-2021-01325
• Device Sequence Number: 2990364
• Product Code: MBI
• UDI-Device Identifier: 03596010621627
• UDI-Public: 03596010621627
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K083635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/16/2025
• Device Model Number: 72202267
• Device Catalogue Number: 72202267
• Device Lot Number: 50852269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Initial Date Received by Manufacturer: 05/19/2021
• Supplement Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 07/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Weight: 57