MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX ULTRA PK 4.5MM W/2 UB -WHT &BL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72202595

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 06/11/2020

Event Type  Injury  

Manufacturer Narrative

Foreign zip code: (b)(6).

Event Description

It was reported that, during a rotator cuff repair surgery, a 3.8mm awl was used to drill the hole and it was found the "twinfix ultra peek anchor (4.5mm)" fractured outside the patient.The procedure was successfully completed without significant delay using a back-up device into the same bone hole.No 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

H3,h6: the reported 4.5 twinfix ultra pk anchor assembly, used in treatment, has been returned for evaluation.Visual assessment of the device confirmed the reported complaint of breakage.The distal end of the anchor has broken at the suture eyelet.Removal of the anchor from the inserter showed one of the inserter tines is bent and twisted.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: use of excessive force during insertion.Off axis insertion of the anchor.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.

• Brand Name: TWINFIX ULTRA PK 4.5MM W/2 UB -WHT &BL
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10207332
• MDR Text Key: 196923809
• Report Number: 1219602-2020-00959
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010647467
• UDI-Public: 03596010647467
• Combination Product (y/n): N
• PMA/PMN Number: K093897
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72202595
• Device Catalogue Number: 72202595
• Device Lot Number: 2032796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Date Manufacturer Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 65