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

Model Number	72203986
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/07/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the second anchor pre-deployed during the surgery.A backup device was used to complete the surgery.No significant delay or patient injury reported.
Additional Manufacturer Narrative
One tfcc fast fix kit was returned for evaluation.Visual assessment of the device showed the kpsc and fast-fix device are intact and sealed within their sterile pouches.Device in question was not returned for evaluation prohibiting confirmation of the reported complaint of pre-deployment.The unused device was removed from its packaging and was found to be intact.

• 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: 7372178
• Report Number: 1219602-2018-00373
• Device Sequence Number: 2311930
• Product Code: GAT
• UDI-Device Identifier: 00885554032154
• UDI-Public: (01)00885554032154(17)200927(10)50687794
• Combination Product (Y/N): N
• PMA/510(K) Number: K132079
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2018

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: 09/27/2020
• Device Model Number: 72203986
• Device Catalogue Number: 72203986
• Device Lot Number: 50687794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2018
• Initial Date Received by Manufacturer: 03/07/2018
• Supplement Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 03/26/2018
• Supplement Report FDA Received Date: 05/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1