MAUDE Adverse Event Report: ARTHREX, INC. IBAL UKA, FEMORAL PEG DRILL, DIA. 260; ORTHOPEDIC MANUAL SURG INSTR

Model Number	IBAL UKA, FEMORAL PEG DRILL, DIA. 260
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/20/2023
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
On 06/21/2023, it was reported by a sales representative via sems that an ar-611-10 tibia peg drill and ar-611-11 femoral peg drill are worn and pieces are starting to shave off.This was discovered during a case and produced debris.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed based on the customer-provided pictures.Visual evaluation of the customer-provided pictures noted damage to the device along with discoloration to the surface.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 overstressing a device that is damaged naturally and inevitably as a result of normal wear or aging from repeated usage/reprocessing.Manufactured date: 07-dec-2018.

• Brand Name: IBAL UKA, FEMORAL PEG DRILL, DIA. 260
• 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: 21111635
• Report Number: 1220246-2025-09291
• Device Sequence Number: 8760164
• Product Code: LXH
• UDI-Device Identifier: 00888867223905
• UDI-Public: 00888867223905
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 03/07/2025

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: IBAL UKA, FEMORAL PEG DRILL, DIA. 260
• Device Catalogue Number: AR-611-11
• Device Lot Number: 021847
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2023
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2018
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown