MAUDE Adverse Event Report: ARTHREX, INC. AC TIGHTROPE REPAIR KIT, TITANIUM; WASHER, BOLT, NUT

Model Number	AC TIGHTROPE REPAIR KIT, TITANIUM
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event has not yet been determined as the device has not been returned for evaluation at this time.A follow-up report will be submitted, including a most likely cause if a root cause can not be determined.
Event or Problem Description
On 6/12/2023, it was reported by an arthrex employee via email that an ar-2257 ac tightrope was implanted during an open reduction and internal fixation of the left clavicle fracture procedure on (b)(6) 2023.One month later, an x-ray scan showed the plate was loosened.A revision surgery was performed to remove the plate and a product from another company we used to complete the procedure.Additional information received on 6/13/2023: the plate that was loosened was from another manufacture.The ar-2257 ac tightrope was explanted during the revision surgery on (b)(6) 2023.
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 a patient-specific event.

• Brand Name: AC TIGHTROPE REPAIR KIT, TITANIUM
• 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: emily shafer ; 8009337001
• MDR Report Key: 17266534
• Report Number: 1220246-2023-07046
• Device Sequence Number: 14930373
• Product Code: HTN
• UDI-Device Identifier: 00888867026391
• UDI-Public: 00888867026391
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K052776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: AC TIGHTROPE REPAIR KIT, TITANIUM
• Device Catalogue Number: AR-2257
• Device Lot Number: 26723
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2023
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown