MAUDE Adverse Event Report: ARTHREX, INC. PROXIMAL TENODESIS IMPLANT SYSTEM REV: 0; NON-DEGRADABLE FIXATN FASTENER

Model Number	PROXIMAL TENODESIS IMPLANT SYSTEM REV: 0
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	10/15/2024
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 biceps surgery the biceps button on the inserter broke off when the surgeon was inserting it into the drill hole.A piece of the inside of the inserter got stuck on the button.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.
Event or Problem Description
Update avoe 05-dec-2024.It was confirmed that the button did not break and remained in the patient.There was no fragment loose in the patient.
Additional Manufacturer Narrative
Additional information: b5, h3, h6.
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 user error of the device due to applying excessive mechanical forces and/or prying/leveraging the device during use.

• Brand Name: PROXIMAL TENODESIS IMPLANT SYSTEM REV: 0
• Common Device Name: NON-DEGRADABLE FIXATN 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: 20557455
• Report Number: 1220246-2024-08301
• Device Sequence Number: 3103230
• Product Code: MBI
• UDI-Device Identifier: 00888867026698
• UDI-Public: 00888867026698
• 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,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/21/2025

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: PROXIMAL TENODESIS IMPLANT SYSTEM REV: 0
• Device Catalogue Number: AR-2290
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2024
• Supplement Date Received by Manufacturer: Not provided; 10/20/2025
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 01/02/2025; 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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