MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE PK 8 X 30MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72202269
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that, during an acl procedure, the surgeon was inserting the biosure pk screw in the 7.5 mm tibial tunnel, the screw threaded on itself rendering unusable.All items were removed from within the patient.There was a backup device available.No delay or patient injury was reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10 h3, h6: the reported 8x30mm biosure pk screw, used in treatment, has not been returned for evaluation.Without the reported product a visual evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, when inserting the biosure pk screw in the 7.5 mm tibial tunnel, the screw threaded on itself rendering unusable.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: not preparing the insertion site with the proper pre device.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the manufacturing and complaint records was performed, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: BIOSURE PK 8 X 30MM
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9822002
• Report Number: 1219602-2020-00510
• Device Sequence Number: 11530378
• Product Code: MBI
• UDI-Device Identifier: 03596010622051
• UDI-Public: 03596010622051
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K083635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2020

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: 01/31/2024
• Device Model Number: 72202269
• Device Catalogue Number: 72202269
• Device Lot Number: 50785348
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/16/2020
• Supplement Date Received by Manufacturer: 04/03/2020
• Initial Report FDA Received Date: 03/11/2020
• Supplement Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1