MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWNFX TI 5.0 STR ANCHR W/2 ULTRB STR N; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	7210708
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, during use, the twinfix got pulled out from the bone suture, also, the anchor was broken.The procedure was completed with a s+n back up device.No significant delay and no patient injury or other complications were reported.
Additional Manufacturer Narrative
H3, h6: 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 complaint history review concluded this was a repeat issue.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.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.A review of the anchor specifications found that no burrs, cracks, or contamination is allowed.A certification of compliance to material and processing specifications is required.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 reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: TWNFX TI 5.0 STR ANCHR W/2 ULTRB STR N
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 12436458
• Report Number: 1219602-2021-01882
• Device Sequence Number: 17038790
• Product Code: MBI
• UDI-Device Identifier: 03596010532206
• UDI-Public: 03596010532206
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K972326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2021

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: 06/11/2025
• Device Model Number: 7210708
• Device Catalogue Number: 7210708
• Device Lot Number: 2056264
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/21/2021
• Supplement Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 09/07/2021
• Supplement Report FDA Received Date: 10/14/2021
• 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