MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE PK 6 X 25MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72202260
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/07/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an acl the biosure scattered into few smaller pieces a 1,5 cm of the screw stayed inside, it has to be retrieved piece by piece.A competitor devices was used in the same bone hole and all the pieces were removed.The procedure was completed without a significant delay.No 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
The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future occurrence of the reported event.A review of the device history 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 instructions for use found certain site preparation techniques may contribute to breakage.A review of risk management files found that the reported failure was documented appropriately.A review of the complaint revealed there were no patient injuries reported and no apparent patient impact based on the details provided.Therefore, no further medical assessment is warranted.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: BIOSURE PK 6 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: 10623360
• Report Number: 1219602-2020-01512
• Device Sequence Number: 3054322
• Product Code: MBI
• UDI-Device Identifier: 03596010621986
• UDI-Public: 03596010621986
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/15/2024
• Device Model Number: 72202260
• Device Catalogue Number: 72202260
• Device Lot Number: 50840100
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/07/2020
• Supplement Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 10/02/2020
• Supplement Report FDA Received Date: 04/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention