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

Model Number 7210752

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/24/2020

Event Type  malfunction  

Event Description

It was reported that during a meniscus repair, when the meniscus mender pack was opened, it was found that the two metals loops were broken off.The procedure was completed without delay using a back-up device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The device, which was used in a procedure, was not returned for evaluation.A relationship between the device and the reported incident could not be confirmed.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.A complaint history review found other related failures.Factors that are known to contribute to the alleged fault/failure may be shipping damage, a component failure, or handling.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.If the product is returned in the future the complaint can be reopened and evaluated.

• 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: 10410952
• MDR Text Key: 203104704
• Report Number: 1219602-2020-01257
• 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: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 09/25/2020

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
• Device Operator: Health Professional
• Device Model Number: 7210752
• Device Catalogue Number: 7210752
• Device Lot Number: 2041140
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/24/2020
• Initial Date FDA Received: 08/14/2020
• Supplement Dates Manufacturer Received: 07/24/2020
• Supplement Dates FDA Received: 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1