MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TFCC MENDER DISPOSABLE SUTURE SYSTEM; PASSER

Model Number	7210752
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a meniscus repair, when the surgeon was trying to catch the suture, the snare top handle of the tfcc mender suture system kit was broken.It was attempted twice, but both pieces of the snares in the same tfcc mender suture system kit were easily broken.Non-significant delay was reported, and the procedure was finished with a smith and nephew back up device.No further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a meniscus repair, when the surgeon was trying to catch the suture, the snare top handle of the tfcc mender suture system kit broke in two pieces.It was attempted twice, but both pieces of the snares in the same tfcc mender suture system kit were easily broken.Non-significant delay was reported, and the procedure was finished with a fast-fix 360.No further complications were reported.
Additional Manufacturer Narrative
H10: additional information: updated b5 and h6 (medical device problem code).
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).The reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was a relationship found between the device and the reported event.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.An analysis of the customer provided image found the hub was broken away from the shaft of the suture capture loops.The root cause has been associated with unintended use of the device.Factors that could have contributed to the failure include an application of unintended inappropriate or excessive force to the device.No containment or corrective actions are recommended at this time.

• Brand Name: TFCC MENDER DISPOSABLE SUTURE SYSTEM
• Common Device Name: PASSER
• 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: 17288265
• Report Number: 1219602-2023-01095
• Device Sequence Number: 5523475
• Product Code: HWQ
• UDI-Device Identifier: 03596010563279
• UDI-Public: 03596010563279
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K885311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/29/2023

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 Model Number: 7210752
• Device Catalogue Number: 7210752
• Device Lot Number: 2089235
• 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: 06/20/2023
• Supplement Date Received by Manufacturer: 07/06/2023; 11/24/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 07/13/2023; 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2022
• 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