MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX TI 5.0 ULTRABRAID; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 72200755

Device Problem Break (1069)

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

Event Date 12/05/2018

Event Type  malfunction  

Event Description

It was reported that during a shoulder cuff repair surgery the device broke, all pieces were removed.A backup device was available to complete the procedure with no significant delay or patient injuries.

Manufacturer Narrative

One twinfix ti 5.0 anchor assembly was returned for evaluation.Visual assessment confirmed the eyelet portion of the anchor is bent and stripped.The proximal threads of the anchor are also damaged.The hex portion of the inserter was dimensionally inspected and found to meet print specification.The condition of the anchor indicates it was subjected to an excessive amount of torque during insertion.

• Brand Name: TWINFIX TI 5.0 ULTRABRAID
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• 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: jim gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 8198168
• MDR Text Key: 131475884
• Report Number: 1219602-2018-01795
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010577986
• UDI-Public: 03596010577986
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K972326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2022
• Device Catalogue Number: 72200755
• Device Lot Number: 50675956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 35