MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TFCC FAST FIX KIT; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	72203986
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign zip code: (b)(6).
Event or Problem Description
It was reported that during a wrist surgery after t1 was deployed, the internal rod did not retract, causing a simultaneous deployment.An open surgery was performed to retrieve t2 and the suture material was removed from the joint space.No significant delay was reported.A back up device was available to complete the procedure.
Additional Manufacturer Narrative
One tfcc fast fix was returned for evaluation.Visual assessment of the device confirmed no ts or sutures remain on the delivery needle and were not returned for examination.The actuator is protruding out of the distal end of the delivery needle.The device was functionally tested for proper actuator advancement and cycling and was found to function as intended.

• Brand Name: TFCC FAST FIX KIT
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8445720
• Report Number: 1219602-2019-00335
• Device Sequence Number: 14184414
• Product Code: GAT
• UDI-Device Identifier: 00885554032154
• UDI-Public: 00885554032154
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K132079
• 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): 06/06/2019

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: 05/15/2021
• Device Catalogue Number: 72203986
• Device Lot Number: 50735658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2019
• Initial Date Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 03/22/2019
• Supplement Report FDA Received Date: 06/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 24 YR