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

Model Number	BUR,OVAL,FLUSHCUT,RETR,8 FLUT,5.5MMX13CM
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, it was reported by a sales representative via email that an ar-8550rfoe retractable flushcut burr tip broke off from the shaft.Surgeon was able to retrieve the piece from the patient's shoulder and complete case with another burr.This was discovered during a shoulder scope distal clavicle excision procedure on (b)(6) 2022.
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
Complaint is confirmed.One unpackaged (b)(6) retractable flushcut burr, oval, 8 flute, 5.0 mm x 13 cm serial/batch number unk was received for investigation.No functional test was performed because the device was received disassembled/broken.Visual evaluation found that the inner tube broke off at the tip.No fragments were returned for investigation.The cause remains undetermined.

• Brand Name: BUR,OVAL,FLUSHCUT,RETR,8 FLUT,5.5MMX13CM
• Common Device Name: BURR, SURGICAL, GENERAL & PLASTIC SURGERY
• 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: vik bajnath ; 8009337001
• MDR Report Key: 15914212
• Report Number: 1220246-2022-05860
• Device Sequence Number: 6544279
• Product Code: GFF
• UDI-Device Identifier: 00888867259799
• UDI-Public: 00888867259799
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 03/13/2023

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: 14988898
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2022
• Supplement Date Received by Manufacturer: 11/17/2022
• Initial Report FDA Received Date: 12/05/2022
• Supplement Report FDA Received Date: 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown