MAUDE Adverse Event Report: ARTHREX, INC. BURR, OVAL, 8 FLUTE 4.0MM X 13CM; BURR,SURGICAL

Model Number	BURR, OVAL, 8 FLUTE 4.0MM X 13CM
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 9/12/2023, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-8400obe burr had an issue during an unspecified procedure on (b)(6) 2023.The burr appeared to devastate/destroy upon contact with the bone, causing debris to be visible to the arthroscope.The burr did not break, only its teeth shed debris.The device was discarded by the facility.This occurred during use with no patient harm.Additional information has been requested.On 9/22/2023, the arthrex subsidiary employee provided the following information via email: this occurred during a knee arthroscopy procedure.The burr was no longer needed after the roughing.The debris was complicated to collect since they were very fine pieces.It was hoped that after vacuuming, most of those tiny pieces that looked like dust were removed.Dualwave outflow tubing was not used, and there was a constant, uninterrupted flow of irrigation through the device during its use.The procedure was completed successfully.There was a case delay of approximately 5 minutes reported.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
The complaint is confirmed based on the customer provided photo, which shows abrasion marks around the inner tip of the outer tube.The most likely cause of this failure is attributed to user error, per dfu-0215-eo rev 1 section f- precautions- 7.Excessive "side-loading" on the device during use does not improve cutting performance and in extreme cases will cause irreversible damage to the device.9.Irreversible damage to all devices will result if they are run without the flow of irrigation (dry).

• Brand Name: BURR, OVAL, 8 FLUTE 4.0MM X 13CM
• 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: emily shafer ; 8009337001
• MDR Report Key: 17897644
• Report Number: 1220246-2023-08108
• Device Sequence Number: 6998413
• Product Code: GFF
• UDI-Device Identifier: 00888867043602
• UDI-Public: 00888867043602
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2024

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: BURR, OVAL, 8 FLUTE 4.0MM X 13CM
• Device Catalogue Number: AR-8400OBE
• Device Lot Number: 15097361
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2023
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/26/2023
• 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