MAUDE Adverse Event Report: ARTHREX, INC. GAP DRILL GUIDE; ORTHOPEDIC MANUAL SURG INSTR

Model Number	GAP DRILL GUIDE
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2024
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 meniscus extrusion surgery the setting tool detached from the target guidance.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with the same device used anyway.It was not necessary to switch the surgical technique or do a second surgery.14-jan-2025: received further information that during a medial meniscotibial ligament repair surgery the tip broke off while placing the setting tool over the drill wires.
Additional Manufacturer Narrative
One unpackaged ar-5875g gap¿ drill guide 3.0 mm offset was received for investigation.Visual evaluation of the returned device noted that the drill guide component was no longer attached to the shaft of the device as the weld had broken.Functional testing was not performed due to the damage to the device.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 mating instruments during use.

• Brand Name: GAP DRILL GUIDE
• 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: 21170331
• Report Number: 1220246-2025-09493
• Device Sequence Number: 17227433
• Product Code: LXH
• UDI-Device Identifier: 00888867307506
• UDI-Public: (01)00888867307506(11)201026(17)250930(10)11975086
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 03/28/2025

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 Expiration Date: 09/30/2025
• Device Model Number: GAP DRILL GUIDE
• Device Catalogue Number: AR-5875G
• Device Lot Number: 11975086
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2024
• Supplement Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2020
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown