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

Catalog Number	72201492
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an arthroscopy, when the surgeon activated the second suture of the ultra fast-fix did not release and remained stuck.The suture was removed with tweezers.The procedure was completed using a back-up device.There was a delay less than 30 minutes and no further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).A device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.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.Please refer to the instructions for use for precautions and warnings related to the use of the device.Based on this investigation, the need for corrective action is not indicated.If any additional information related to this event is received in the future, this investigation will be reopened for evaluation.
Event or Problem Description
It was reported that during an arthroscopy, when the surgeon activated the second suture of the ultra fast-fix did not release and remained stuck.The suture was removed with tweezers.The procedure was completed using a back-up device.There was a delay less than 30 minutes and no further complications were reported.Patient current status is stable.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).B5: description updated.

• 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: 19978197
• Report Number: 1219602-2024-01740
• Device Sequence Number: 2846709
• Product Code: GAT
• UDI-Device Identifier: 03596010597212
• UDI-Public: 3596010597212
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K121861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/11/2024

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 Catalogue Number: 72201492
• Device Lot Number: 2107623
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2024
• Supplement Date Received by Manufacturer: 09/09/2024; 09/09/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 09/10/2024; 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2022
• 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
• Patient Sex: Unknown