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 Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 17th july 2025, it was reported by a distributor via email that for an ar-8919ds, implant system, cmc mini tightrope, 1.1 mm, during the final fixation of druj, it was found that the button was not attached on the cortical bone properly.The surgeon found the suture was broken.This was detected during use in an open reduction internal fixation of distal radius ulnar joint procedure on (b)(6) 2025.The procedure was completed successfully using an additional mini tightrope.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.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 the most likely cause.The most likely cause of the reported failure is user error, including improper bone preparation and incorrect surgical technique during device application.These factors may have contributed to the malfunction or compromised the integrity of the implant during the procedure.The complaint allegation was confirmed based on the customer¿s attached image, which showed a broken suture system and damaged buttons.

• 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: 22727084
• Report Number: 1220246-2025-03272
• Device Sequence Number: 18214746
• Product Code: HTN
• UDI-Device Identifier: 00888867048966
• UDI-Public: (01)00888867048966(11)240429(17)290331(10)15240833
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Followup
• Report Date (Section B): 11/20/2025

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: 15240833
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/17/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown