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

Model Number	KNOTLESS AC TIGHTROPE REPAIR SYSTEM
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during a dac surgery it was found that the drill had no cannulation when the surgeon tried to open the drill in order to insert the nitinol wire.The surgery as changed and finished with a tigerstick (ar-7209t) in order to replace the cannulated drill.Per complaint reporter there was no harm for patient, operator or third party.
Event or Problem Description
Update dw 01-oct-2024: further information was provided that the event occurred during a disjonction acromio-claviculaire.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to a manufacturing issue; however, due to the device not being returned and no photographs of the event being provided, we are unable to confirm the reported event.

• Brand Name: KNOTLESS AC TIGHTROPE REPAIR SYSTEM
• 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: 20270632
• Report Number: 1220246-2024-07792
• Device Sequence Number: 3365634
• Product Code: HTN
• UDI-Device Identifier: 00888867340145
• UDI-Public: (01)00888867340145(11)240122(17)281231(10)15196281
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K220947
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/27/2025

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: KNOTLESS AC TIGHTROPE REPAIR SYSTEM
• Device Catalogue Number: AR-2371BL
• Device Lot Number: 15196281
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 10/01/2024; 05/12/2025
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 10/10/2024; 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2024
• 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