MAUDE Adverse Event Report: ARTHREX, INC. DEPTH GUIDE FOR 3.0 MM QUICKFIX SCREW; ORTHOPEDIC MANUAL SURG INSTR

Model Number	DEPTH GUIDE FOR 3.0 MM QUICKFIX SCREW
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, it was reported by a sales representative via sems (b)(4) that during a procedure the surgeon went to start implanting screws into the patient when the ar-8970rh handle was not ratcheting and an ar-8930g depth gauge shows an incorrect number.After the surgeon implanted four screws, he went to check the x-ray, and every screw was too long.He checked the device and when the device was pulled all the way back to a length of 0mm, it showed 10mm.
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: 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 wear and tear.The manufacturing date is 2018.

• Brand Name: DEPTH GUIDE FOR 3.0 MM QUICKFIX 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: 19075500
• Report Number: 1220246-2024-01927
• Device Sequence Number: 12468933
• Product Code: LXH
• UDI-Device Identifier: 00888867049260
• UDI-Public: 00888867049260
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2025

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: DEPTH GUIDE FOR 3.0 MM QUICKFIX SCREW
• Device Catalogue Number: AR-8930G
• Device Lot Number: 1489181900
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2024
• Supplement Date Received by Manufacturer: 05/17/2025
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2018
• Is the Device Labeled for Single Use? (Y/N): No
• 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