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 Material Separation (1562)

Patient Problem No Information (3190)

Event Date 08/17/2020

Event Type  Injury  

Event Description

It was reported that, during a rotator cuff repair surgery, the "4.5mm twinfix ultrapeek anchor" fractured at distal zone when it was screwed in.All the pieces were successfully removed using tweezers.The procedure was successfully completed without significant delay using a back-up device into the same bone hole.No further 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 72202595 reported 4.5 twinfix ultra pk anchor assembly, used in treatment, has been returned for evaluation.From the information provided, the anchor fractured.Visual assessment of the device confirmed the reported complaint.The tip of the anchor is fractured.The sutures remain on the knob.The condition of the device indicates it was subjected to excessive forces during use.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.Complaint history review indicated no similar allegations for the lot number reported.Batch review did not indicate a condition, product or procedure failure that supported the allegation.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: 10500199
• MDR Text Key: 205883519
• Report Number: 1219602-2020-01363
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010647467
• UDI-Public: 03596010647467
• Combination Product (y/n): N
• 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: 10/15/2020

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 Expiration Date: 04/07/2024
• Device Model Number: 72202595
• Device Catalogue Number: 72202595
• Device Lot Number: 2031053
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/17/2020
• Initial Date FDA Received: 09/07/2020
• Supplement Dates Manufacturer Received: 08/17/2020
• Supplement Dates FDA Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR
• Patient Weight: 60