MAUDE Adverse Event Report: ARTHREX, INC. DRIVER, BIOCOMPOSITE INTERFERENCE SCREW; ORTHOPEDIC MANUAL SURG INSTR

Model Number	DRIVER, BIOCOMPOSITE INTERFERENCE SCREW
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the reconstruction of the medial patellofemoral ligament the tip of the driver broke off.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The reported event was not confirmed as the visual evaluation of the received ar-1996cd, lot: 67251426 revealed that the distal end of the shaft is partly bent and not broken off (see evaluation picture 3 + 4).The most likely cause for the reported failure can be attributed to user-applied excessive force during the tightening process.Further, the tip shows several notches.

• Brand Name: DRIVER, BIOCOMPOSITE INTERFERENCE SCREW
• 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: 22686312
• Report Number: 1220246-2025-03186
• Device Sequence Number: 9000326
• Product Code: LXH
• UDI-Device Identifier: 00888867025707
• UDI-Public: (01)00888867025707(10)67251426
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• 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): 08/18/2025

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: DRIVER, BIOCOMPOSITE INTERFERENCE SCREW
• Device Catalogue Number: AR-1996CD
• Device Lot Number: 67251426
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown