MAUDE Adverse Event Report: ARTHREX, INC. IMPL SYS,CMC MINI T-ROPE,1.1 MM; WASHER, BOLT NUT

Model Number IMPL SYS,CMC MINI T-ROPE,1.1 MM

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/02/2022

Event Type  malfunction  

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.

Event Description

On (b)(6) 2022, it was reported by a distributor via email that an ar-8919ds cmc mini tightrope nitinol loop broke off in the k-wire within the first metacarpal tunnel.The loop was retrieved and removed from inside patient, another cmc mini tightrope was opened.The loop broke again in the tunnel, just like the previous one; however, this remain partially intact with the wire and did not need to be removed.This was discovered during a thumb mcm suspensionplasty procedure on (b)(6) 2022 but was completed as an lrti procedure instead.

• Brand Name: IMPL SYS,CMC MINI T-ROPE,1.1 MM
• Type of Device: WASHER, BOLT NUT
• 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: 14546916
• MDR Text Key: 300735176
• Report Number: 1220246-2022-04970
• Device Sequence Number: 1
• Product Code: HTN
• UDI-Device Identifier: 00888867048966
• UDI-Public: 00888867048966
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K140328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMPL SYS,CMC MINI T-ROPE,1.1 MM
• Device Catalogue Number: AR-8919DS
• Device Lot Number: 14913292
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/09/2022
• Date Device Manufactured: 01/11/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1