MAUDE Adverse Event Report: ARTHREX, INC. NANO CORKSCREW FT, TI, W 3-0 FW; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number NANO CORKSCREW FT, TI, W 3-0 FW

Device Problems Break (1069); Material Frayed (1262); Defective Device (2588)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/14/2022

Event Type  malfunction  

Event Description

On 6/14/2022 it was reported by a sales representative via sems that an ar-1318ft suture anchor broke during a ulnar sheath repair.The implant broke during insertion where the driver meets the anchor and the sutures were frayed.All was retrieved.A second suture anchor was used and that one also frayed the sutures during insertion.All debris was retrieved and the procedure was completed successfully.No further information provided.Additional information: they were unable to remove the second defective anchor from the patient.It is countersunk in the bone but will not cause irritation.To complete the case a larger anchor was used (micro corkscrew) in the same drill hole as an alternative.

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

• Brand Name: NANO CORKSCREW FT, TI, W 3-0 FW
• Type of Device: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 14914528
• MDR Text Key: 304292633
• Report Number: 1220246-2022-05155
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00888867276703
• UDI-Public: 00888867276703
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180118
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NANO CORKSCREW FT, TI, W 3-0 FW
• Device Catalogue Number: AR-1317FT
• Device Lot Number: 12839226
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/14/2022
• Date Device Manufactured: 03/03/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1