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	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint confirmed, abrasion marks were observed around the od of the flute, and the cutting edges are dented and dull.A likely cause of the event is wear and tear.
Event or Problem Description
On 11/17/2021 it was reported by a sales representative via (b)(4) that an ar-611-11 peg drill is worn.This was discovered during use in a procedure on 11/17/2021.The case was completed by swapping out the camera head.

• 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: 19280115
• Report Number: 1220246-2024-03048
• Device Sequence Number: 6339214
• 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
• Report Date (Section B): 05/09/2024

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: 022103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2021
• 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