MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX AB 5.0 SUTR ANCHR W/2 38 ULTRA; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	72200777
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/24/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery, before implantation the doctor was unhappy with the twinfix suture anchor.The procedure was completed with a competitor device with no delay or other complications.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 facility for independent evaluation, thus visual inspection and functional testing could not be performed.There was a relationship found between the subject device and the reported incident.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.An assessment of the customer provided images found the device appears crushed and the suture is showing through the breakage.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of risk management files found that the reported failure was documented appropriately.The complaint was confirmed.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: TWINFIX AB 5.0 SUTR ANCHR W/2 38 ULTRA
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10694733
• Report Number: 1219602-2020-01606
• Device Sequence Number: 3933875
• Product Code: MAI
• UDI-Device Identifier: 03596010578150
• UDI-Public: 03596010578150
• Combination Product (Y/N): N
• Initial Reporter Country: NP
• PMA/510(K) Number: K151105
• 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): 04/10/2021

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: 04/18/2021
• Device Model Number: 72200777
• Device Catalogue Number: 72200777
• Device Lot Number: 2012914
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/24/2020
• Supplement Date Received by Manufacturer: 04/08/2021
• Initial Report FDA Received Date: 10/18/2020
• Supplement Report FDA Received Date: 04/10/2021
• 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