MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX ULTRA PLLA/HA 6.5 W/3 UB; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number 72202610

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/04/2024

Event Type  Injury  

Manufacturer Narrative

H10: internal complaint reference (b)(4).

Event Description

It was reported that during a shoulder arthroscopy with rc repair, two (2) twinfix ultra anchors broke during insertion.The insertion site was prepared with the awl 3.8 mm, the patient had normal bone quality.One of the broken anchors could not be retrieved entirely.The procedure was completed with a s+n back up device.There was a delay less than 30 minutes and no further complications were reported.

• Brand Name: TWINFIX ULTRA PLLA/HA 6.5 W/3 UB
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 19193604
• MDR Text Key: 341169091
• Report Number: 1219602-2024-00890
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 03596010647627
• UDI-Public: 03596010647627
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K151105
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72202610
• Device Lot Number: 2123147
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2024
• Date Device Manufactured: 06/22/2023
• 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 Outcome(s): Required Intervention; Other
• Patient Sex: Male