MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE PK 7 X 25MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72202263
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: case-2021-00035867-1.
Event or Problem Description
It was reported that during a cl reconstruction surgery the biosure had a foreign matter in the package.The procedure was successfully completed without a significant delay using a back-up device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).The reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.An analysis of the customer provided image confirmed that there was a particulate within the package.A visual inspection revealed that the sterilization pouch had not been opened or altered.There was a small piece of plastic, the same color as the device, in the bottom left corner of the sealed package.The device had an indentation of a very similar size and shape at the location of the gate break hole.This piece could have been a part of the flash that broken off during sterilization or shipping and nestled itself into the packaging.A review of the device records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A review of the drawing found that when visually inspected, parts must not have dust, lubricants, contaminates, other foreign matter, or embedded particulate.The gate vestige is specified and a gate break hole is acceptable.The complaint was confirmed and the root cause was associated with transport or storage.Factors that could have contributed to the reported event include rough shipping and handling causing the flash to rub off, movement causing flashing to loosen, or an impact event during transportation or at the customer site.

• Brand Name: BIOSURE PK 7 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: 11200780
• Report Number: 1219602-2021-00165
• Device Sequence Number: 2384949
• Product Code: MBI
• UDI-Device Identifier: 03596010621610
• UDI-Public: 03596010621610
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K083635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2021

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: 08/21/2024
• Device Model Number: 72202263
• Device Catalogue Number: 72202263
• Device Lot Number: 50823762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Initial Date Received by Manufacturer: 01/04/2021
• Supplement Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 01/20/2021
• Supplement Report FDA Received Date: 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 65