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

Model Number 7210752

Device Problem Material Separation (1562)

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

Event Date 02/06/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that, during a knee surgery, a screw broke while being tapped. It is unknown whether all fragments were retrieved from the patient. A back-up screw went in and held. It is unknown how long surgery was delayed. The patient was not harmed. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.

• Brand Name: TFCC MENDER DISPOSABLE SUTURE SYSTEM
• Type of Device: PASSER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 9772685
• MDR Text Key: 182169448
• Report Number: 1219602-2020-00448
• Device Sequence Number: 1
• Product Code: HWQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K885311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/31/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/13/2022
• Device Model Number: 7210752
• Device Catalogue Number: ED7210752
• Device Lot Number: 50646756
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial