MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ULTRA FAST-FIX ASSY - REVERSE CURVE; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	72201492
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during an arthroscopy surgery, the fast-fix t2 could not be deployed.The procedure was successfully completed without a significant delay using a back-up device.No other complications were reported.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
The reported device was received for evaluation.A visual inspection revealed the device was returned outside of original packaging.The t2 anchor was attached to the needle.The suture was removed from the anchor and device.The t1 anchor was not returned with the device.The distal tip of the needle on one side was indented.The actuator was fully triggered.A functional evaluation revealed that using a reference meniscus the t2 anchor could not be pushed off as intended due to indention in needle.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found no similar reported events.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 risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause was associated with unintended use of the device.Factors, which could have contributed to the complaint event, include an application of unintended inappropriate or excessive force.No containment or corrective actions are recommended at this time.

• Brand Name: ULTRA FAST-FIX ASSY - REVERSE CURVE
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13546726
• Report Number: 1219602-2022-00240
• Device Sequence Number: 5125634
• Product Code: GAT
• UDI-Device Identifier: 03596010597212
• UDI-Public: 03596010597212
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K072322
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2023

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: 06/20/2025
• Device Model Number: 72201492
• Device Catalogue Number: 72201492
• Device Lot Number: 2057038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2022
• Supplement Date Received by Manufacturer: 07/04/2023
• Initial Report FDA Received Date: 02/16/2022
• Supplement Report FDA Received Date: 07/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 54 KG