MAUDE Adverse Event Report: ARTHREX, INC. PROXIMAL TENODESIS BUTTON REV: 0; NON-DEGRADABLE FIXATION FASTENER

Model Number	PROXIMAL TENODESIS BUTTON REV: 0
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/22/2024
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
It was reported that during a refixation of the long biceps tendon the implant broke off when the surgeon inserted it.The broken piece was retrieved out of the patient and the surgery was finished successfully with a different device.It was not necessary to switch the surgical technique or do a second surgery.Update dw 29-feb-2024: it was further reported that the thread of the inserter broke off.The implant has been implanted correctly.The broken thread was removed.The operation was successfully completed with the same implant.
Additional Manufacturer Narrative
Complaint allegation is confirmed.Upon visual inspection, it was noted that a fragment of the threaded distal end of the shaft assembly is lodged within the m1x0.25 fully threaded hole of the 9mm proximal biceps button of the proximal tenodesis button system.Functional testing was not performed due to the damage to the threaded shaft.The method of bone preparation and the quality of the bone encountered were not provided.Per dfu-0143-eo rev 0 - precautions- 3.Retrobutton only: measurements of intraosseous length and socket depth are critical for proper implant selection.4.Loop and button should be properly oriented during passing and fixation, per technique guide, in order to function properly.The most likely cause of the reported failure can be attributed to user error of the device due to improper bone preparation, misalignment insertion, and/or prying/leveraging of the device during insertion.Functional testing was not performed due to the damage to the threaded shaft.The method of bone preparation and the quality of the bone encountered were not provided.The most likely cause of the reported failure can be attributed to user error of the device due to improper bone preparation, misalignment insertion, and/or prying/leveraging of the device during insertion.
Event or Problem Description
Update avoe (b)(.6) 2024 further information was received that the wire holding the button broke off directly behind it in the threaded part of the device.Update avoe (b)(6) 2024.It was again confirmed that no part of the device remained inside the patient.

• Brand Name: PROXIMAL TENODESIS BUTTON REV: 0
• Common Device Name: NON-DEGRADABLE FIXATION FASTENER
• 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: 18858565
• Report Number: 1220246-2024-01358
• Device Sequence Number: 11589767
• Product Code: MBI
• UDI-Device Identifier: 00888867026704
• UDI-Public: 00888867026704
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K123341
• 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): 08/21/2024

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: PROXIMAL TENODESIS BUTTON REV: 0
• Device Catalogue Number: AR-2291
• Device Lot Number: 15140443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2024
• Supplement Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2023
• 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