MAUDE Adverse Event Report: ARTHREX, INC. BURR, STRAIGHT, 13MM DIAM. 2.0 MM; BURR,SURGICAL

Model Number	BURR, STRAIGHT, 13MM DIAM. 2.0 MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a minimalinvasive mica surgery the attachment broke off.The end remained attached inside the adaptor.The part broke off outside the patient.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.***update dw (b)(6) 2024: further information was provided by the customer that the initial reported event was incorrect.It was confirmed that the attachment had no issue but an arthrex drill bit has broken off and a part remained stuck inside the attachment.The customer was not able to provide further details which drill bit has broken off however during the evaluation a picture of the end of drill bit has shown that it has a diameter of 2mm and the customer only purchased one ar-300-b001 with the batch 037417 which fits this specification.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The reported event is confirmed.The burr drill was broken inside the burr attachment, most likely due to misuse.This could have been caused by hitting the device with another object, prying or leveraging, or applying excessive bending forces during use.

• Brand Name: BURR, STRAIGHT, 13MM DIAM. 2.0 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: 20685244
• Report Number: 1220246-2024-08528
• Device Sequence Number: 12562097
• Product Code: LXH
• UDI-Device Identifier: 00888867028630
• UDI-Public: (01)00888867028630(11)220314(17)270131(10)037417
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 02/11/2025

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: BURR, STRAIGHT, 13MM DIAM. 2.0 MM
• Device Catalogue Number: AR-300-B001
• Device Lot Number: 037417
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2024
• Supplement Date Received by Manufacturer: 01/20/2025
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2022
• 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