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

Catalog Number	72201492
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference number: (b)(4).
Event or Problem Description
It was reported that during an arthroscopy, the suture of the ultra fast-fix broke when pushed and knot.Both implants were removed from the patient with tweezers.The procedure was completed with a surgical delay of less than 30 minutes using a smith and nephew back up device.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).The reported device was received for evaluation.A visual evaluation showed the device was returned in original packaging with the batch number of the complaint on the label.The t1 and t2 were not returned.A partial suture was returned.Both ends of the returned suture have clean cut threads with no sign of stress.The variable depth straw has not been trimmed.Bio debris is present.A functional evaluation could not be performed because both implants have already been deployed.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 no 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.A review of the suture specifications found that a material certification of analysis is required with each lot.The root cause could not be determined since the reported malfunction could not be duplicated during the investigation.Factors that can contribute to the reported event include application of excessive force to the device or contact with another source.Based on this investigation, the need for corrective action is not indicated.

• 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: 19644718
• Report Number: 1219602-2024-01395
• Device Sequence Number: 12643920
• Product Code: GAT
• UDI-Device Identifier: 03596010597212
• UDI-Public: 03596010597212
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 08/13/2024

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 Expiration Date: 06/27/2024
• Device Catalogue Number: 72201492
• Device Lot Number: 2036337
• 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: 06/07/2024
• Supplement Date Received by Manufacturer: 08/05/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2019
• 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 Age: 30 YR
• Patient Sex: Male
• Patient Weight: 66 KG