MAUDE Adverse Event Report: ARTHREX, INC. BURR, STRAIGHT 12 MM, DIA. 2.2 MM; BURR,SURGICAL

Model Number	BURR, STRAIGHT 12 MM, DIA. 2.2 MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/09/2024
Type of Reportable Event	Serious Injury
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 mis calcaneus osteotomy surgery the device broke off while drilling, without leverage.The broken off piece has been retrieved from the patient.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a foreign sawblade, the surgical technique had to change to an open calcaneus osteotomy.It was not necessary to do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.One unpackaged ar-300-b003 burr, straight 12 mm batch: 073228 was received for investigation.Visual evaluation of the returned device noted that it was broken into two pieces.Dimensional testing was performed by measuring the critical dimension specified in drawing c15363 with a blade micrometer.The measurement for both fragments of the returned device was found to be 2.345 which is in tolerance of the specified 2.35 -0.016.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: BURR, STRAIGHT 12 MM, DIA. 2.2 MM
• Common Device Name: BURR,SURGICAL
• 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: 21069011
• Report Number: 1220246-2025-09195
• Device Sequence Number: 18245050
• Product Code: LXH
• UDI-Device Identifier: 00888867099982
• UDI-Public: (01)00888867099982(11)240623(17)290430(10)073228
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: BURR, STRAIGHT 12 MM, DIA. 2.2 MM
• Device Catalogue Number: AR-300-B003
• Device Lot Number: 073228
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2024
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown