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

Catalog Number	72202269
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/25/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during acl fixation surgery, the surgeon attempted to insert the screw in his usual technique and then noted that the tip of the screw the thread was stripped and could not be started correctly without damaging the graft.A backup device was available to complete the procedure with no delay.No other complications were reported.
Additional Manufacturer Narrative
H10, h3,h6: the reported 72202691 screw, biosure healicoil pk, 8mm x 30mm, intended for use in treatment, has not returned for evaluation.Without the reported product a visual and functional evaluation cannot be performed and the customer¿s complaint cannot be confirmed.From the information provided, ¿during acl fixation surgery, the surgeon attempted to insert the screw in his usual technique and then noted that the tip of the screw the thread was stripped and could not be started correctly without damaging the graft¿.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force applied during use.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.
Additional Manufacturer Narrative
Update part number.

• Brand Name: BIOSURE PK 8 X 30MM
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10300005
• Report Number: 1219602-2020-01086
• Device Sequence Number: 13619882
• Product Code: MBI
• UDI-Device Identifier: 00885556541173
• UDI-Public: 885556541173
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K140879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/27/2020

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 72202269
• Device Lot Number: 50819434
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/25/2020
• Supplement Date Received by Manufacturer: 08/11/2020; 08/11/2020
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 08/12/2020; 08/27/2020
• 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