MAUDE Adverse Event Report: ARTHREX, INC. BUR,OVAL,FLUSHCUT,RETR,8 FLUT,5.5MMX13CM; BURR,SURGICAL

Model Number	BUR,OVAL,FLUSHCUT,RETR,8 FLUT,5.5MMX13CM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 3/5/2024, it was reported by a sales representative via (b)(4) that an ar-8550rfoe retractable flushcut burr head broke off the shaft of the burr and was lodged into the joint after the surgeon took the handpiece out.A grasper was able to retrieve the head of the burr.The case was completed using a new burr.This was discovered during a shoulder procedure on (b)(6) 2024.Additional information was received on 3/12/2024: this was discovered during an arthroscopic rotator cuff repair, distal clavicle, and biceps tenodesis procedure on (b)(6) 2024.There was a slight delay with the defective 5.5 burr.The burr head came entirely off the inner sleeve of the burr.They had a second burr in the room and were able to switch it out quickly.Only inflow was being used, and flow through the defective device was not interrupted.The patient has not experienced any adverse effects as they were able to retrieve all parts of the burr that came apart in the joint with a grasper.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Complaint allegation is confirmed.Upon visual inspection, it was noted that the tip of the inner tube of the retractable flushcut¿ burr, oval, 8 flute, 5.5 mm x 13 cm had broken off.The outer tube was not returned for investigation.Functional testing was not performed due to the damage to the device.The most likely cause of the reported event is user error.Per dfu-0215-eo rev 1.Section f.Precautions 6.Do not allow the rotating portion of any device to touch any metallic object, such as a cannula or arthroscope, during use.Damage to both devices is likely.Damage to the device can range from a slight distortion or dulling of the blade/burr edge to actual fracture of the tip in vivo.If such contact does occur, inspect the tip.If there are cracks, fractures or dulling, or if there is any other reason to suspect a blade is damaged, replace it immediately.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.

• Brand Name: BUR,OVAL,FLUSHCUT,RETR,8 FLUT,5.5MMX13CM
• 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: 18935499
• Report Number: 1220246-2024-01555
• Device Sequence Number: 17885366
• Product Code: GFF
• UDI-Device Identifier: 00888867259799
• UDI-Public: 00888867259799
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Followup
• Report Date (Section B): 08/29/2024

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: BUR,OVAL,FLUSHCUT,RETR,8 FLUT,5.5MMX13CM
• Device Catalogue Number: AR-8550RFOE
• Device Lot Number: 15196306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 08/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2024
• 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