MAUDE Adverse Event Report: ARTHREX, INC. FLEX TAP 7MM BIOCOMP INT SCRW QCK CON; ORTHOPEDIC MANUAL SURG INSTR

Model Number	FLEX TAP 7MM BIOCOMP INT SCRW QCK CON
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a facility representative reported via (b)(4) that an ar-1998ctf-07 flexible biocomposite interference screw tap broke during a case.The point where the flexible reamer bends snapped inside the patient and was able to be retrieved.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is not confirmed.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 of the reported failure can be attributed to wear and tear due to repeated use of the device in the field.Manufacturing date 29-mar-2016.

• Brand Name: FLEX TAP 7MM BIOCOMP INT SCRW QCK CON
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 23757833
• Report Number: 1220246-2025-05509
• Device Sequence Number: 15936214
• Product Code: LXH
• UDI-Device Identifier: 00888867237254
• UDI-Public: (01)00888867237254(11)160329(10)41641612
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

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: FLEX TAP 7MM BIOCOMP INT SCRW QCK CON
• Device Catalogue Number: AR-1998CTF-07
• Device Lot Number: 41641612
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/29/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown