MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA, FEMORAL PEG DRILL; ORTHOPEDIC MANUAL SURG INSTR

Model Number	IBALANCE TKA, FEMORAL PEG DRILL
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/31/2021
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.Visual evaluation reveals circumferential grinding marks on the flute and the edges are deformed, however the device does not appear to be broken.Likely causes include prying/leveraging the device during use.
Event or Problem Description
On 08/31/2021 it was reported by a sale representative via (b)(4) that an ar-613-70 ibalance tka peg drill is worn/stripped.

• Brand Name: IBALANCE TKA, FEMORAL PEG DRILL
• 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: 19213188
• Report Number: 1220246-2024-02610
• Device Sequence Number: 8241373
• Product Code: LXH
• UDI-Device Identifier: 00888867116795
• UDI-Public: 00888867116795
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/30/2024

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: IBALANCE TKA, FEMORAL PEG DRILL
• Device Catalogue Number: AR-613-70
• Device Lot Number: 130641320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown