MAUDE Adverse Event Report: ARTHREX, INC. KL AC TIGHTROPE REPAIR IMP. W/DOG BONE; WASHER, BOLT, NUT

Model Number	KL AC TIGHTROPE REPAIR IMP. W/DOG BONE
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	11/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient was treated with an ac tightrope system on the (b)(6) 2023.The system became loose.The patient checked in post-op and an x-ray was performed.The patient had a grade 5 injury.The surgery was done in the first two weeks.The surgeon did not perform any vertical stabilisation.No further information received.Update avoe 28-mar-2024.It was confirmed that the patient had a grade 5 injury prior to the initial surgery.The failure was detected in the xray in the first appointment after surgery.No actions were taken so far to treat the patient after the loosening of the device.
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.
Additional Manufacturer Narrative
Additional information: d9, g3, h6.Complaint allegation confirmed.Visual inspection via photos confirms that the ac tightrope has loosened.Dfu states: postoperatively and until healing is complete, fixation provided by this device should be considered as temporary and may not withstand weight bearing or other unsupported stress.Dfu-0377-eor2_fmt_en page 3 of 9 the fixation provided by this device should be protected.The postoperative regimen prescribed by the physician should be strictly followed to avoid adverse stresses applied to the device and bone.The most likely cause for the reported failure can be attributed to a patient-specific event.

• Brand Name: KL AC TIGHTROPE REPAIR IMP. W/DOG BONE
• 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: 19153380
• Report Number: 1220246-2024-02205
• Device Sequence Number: 8445979
• Product Code: HTN
• UDI-Device Identifier: 00888867340138
• UDI-Public: 00888867340138
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K220947
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2024

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: KL AC TIGHTROPE REPAIR IMP. W/DOG BONE
• Device Catalogue Number: AR-2370BL
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2024
• Supplement Date Received by Manufacturer: 07/03/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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