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

Model Number 7210752

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/05/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference case: (b)(4).

Event 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.

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
• Type of Device: PASSER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 12088697
• MDR Text Key: 259196353
• Report Number: 1219602-2021-01456
• Device Sequence Number: 1
• Product Code: HWQ
• UDI-Device Identifier: 03596010563279
• UDI-Public: 03596010563279
• Combination Product (y/n): N
• PMA/PMN Number: K885311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 08/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1