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 Break (1069)

Patient Problem No Information (3190)

Event Date 08/17/2020

Event Type  Injury  

Event Description

It was reported that during a shoulder joint surgery, the anchor was fractured when screw-in.The procedure was successfully completed without significant delay using a s&n back-up device.All the pieces were removed from the patient with tweezers.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

One 4.5mm twinfix ultra peek device used in treatment, was returned for evaluation.The insertion device was returned with the anchor and sutures.Suture was still threaded through anchor and the inserter.The anchor was separated from the distal end of the inserter but was not damaged.The inserter shaft distal tip was fractured and the broken piece was stuck inside the proximal end of the anchor.Symptoms align with use of force and potential loss of axial alignment causing the tip to break.It also aligns with an inadequate pilot hole requiring excess torque to be placed upon the inserter to attempt rotations.A 3.8mm tapered awl is the recommended prep instrument for normal bone, or 3.5 mm spade tip drill and 4.5 awl-dilator for hard bone encounter.No indications from the device show cause that the material was related to the reported failure.No root cause related to the manufacturing of this device was confirmed.Product met specifications upon release to distribution.

• 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: 10505328
• MDR Text Key: 206090400
• Report Number: 1219602-2020-01367
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010647467
• UDI-Public: 03596010647467
• Combination Product (y/n): N
• PMA/PMN Number: K093228
• 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: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72202595
• Device Catalogue Number: 72202595
• Device Lot Number: 2035474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Initial Date Manufacturer Received: 08/17/2020
• Initial Date FDA Received: 09/08/2020
• Supplement Dates Manufacturer Received: 10/12/2020
• Supplement Dates FDA Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Weight: 60