MAUDE Adverse Event Report: ARTHREX, INC. MINI TIGHTROPE IMPLANT WITH INSERTER; WASHER, BOLT, NUT

Model Number	MINI TIGHTROPE IMPLANT WITH INSERTER
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2024
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 (b)(6) 2024, it was reported by an arthrex employee via sems (b)(4) that an ar-8913ds drill tip broke when it was drilling with the 2.7mm hollow drill included in the kit.All fragments were removed and there was no impact to the patient.The surgery was completed using the same product from a new kit with the same part number.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.One unpackaged ar-8913ds was received for investigation.Visual inspection noted that the mini tightrope was not sent back for evaluation.Only the drill inserter.The distal end of the drill was broken, and no fragments were returned for investigation.Functional testing was not performed due to the damage of the device.The most likely cause of this condition is excessive force/friction during use or insertion.

• Brand Name: MINI TIGHTROPE IMPLANT WITH INSERTER
• 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: 19229637
• Report Number: 1220246-2024-02704
• Device Sequence Number: 17646260
• Product Code: HTN
• UDI-Device Identifier: 00888867048874
• UDI-Public: 00888867048874
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133275
• 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
• Report Date (Section B): 09/06/2024

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: MINI TIGHTROPE IMPLANT WITH INSERTER
• Device Catalogue Number: AR-8913DS
• Device Lot Number: 15148696
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2024
• Supplement Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2023
• 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