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
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 1220246-2022-04970
• Device Sequence Number: 17411719
• Product Code: HTN
• UDI-Device Identifier: 00888867048966
• UDI-Public: 00888867048966
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K140328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 05/31/2022
• Date Device Manufactured: 01/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown