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

Model Number	7210752
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference case: (b)(4).
Event or Problem Description
It was reported that during a wrist arthroscopy tfcc repair surgery, the handle of the mender disposable broke off.The procedure was completed without significant delay using a back-up device.No patient injury or other complications were reported.
Additional Manufacturer Narrative
H10: h3, h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.A visual inspection revealed the device was returned outside of original packaging.The device showed the hub was broken away from the shaft.The complaint was confirmed and the root cause was associated with device design.Internal complaint reference: (b)(4).

• Brand Name: TFCC MENDER DISPOSABLE SUTURE SYSTEM
• Common Device Name: PASSER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 12088697
• Report Number: 1219602-2021-01456
• Device Sequence Number: 11867599
• Product Code: HWQ
• UDI-Device Identifier: 03596010563279
• UDI-Public: 03596010563279
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K885311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2021

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: 08/20/2025
• Device Model Number: 7210752
• Device Catalogue Number: 7210752
• Device Lot Number: 2059692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2021
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 08/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1