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
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/15/2024
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 4/8/2024, it was reported by a facility risk manager via an fda maude review email that the guidewire from an ar-8919ds cmc mini tightrope implant system broke during insertion.The surgeon attempted to retrieve the broken fragment with a hemostat; however, it bent.The fragment was successfully removed using a needle driver.An x-ray confirmed all the fragments were removed.This was discovered during a procedure on (b)(6) 2024.Additional information received on 4/15/2024: the medwatch notification reports that after the hemostat bent, a needle driver was used to retrieve the broken guidewire.However, when the needle driver was removed from the patient, it was noticed that the tip had broken off.A mini-c-arm x-ray was taken, which showed the tip inside the patient.A portable x-ray was performed to ensure that nothing was retained.The portable x-ray was deemed negative by the doctor.The case was completed, and no follow-up care was needed for the patient.Additional information received on 4/22/2024: the portable x-ray confirmed that the broken tip was never in the patient.Additional information requested.
Additional Manufacturer Narrative
Mw5153301.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.

• 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: jared engle ; 8009337001
• MDR Report Key: 19249585
• Report Number: 1220246-2024-02829
• Device Sequence Number: 20482658
• Product Code: HTN
• UDI-Device Identifier: 00888867048966
• UDI-Public: 00888867048966
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K140328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/19/2025

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: 15077505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided; 05/17/2025
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 07/18/2024; 08/22/2024; 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown