MAUDE Adverse Event Report: ARTHREX, INC. BUR,OVAL,FLUSHCUT,12 FLUT, 5.5MMX 13CM; BURR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	BUR,OVAL,FLUSHCUT,12 FLUT, 5.5MMX 13CM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/26/2021
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that during ac shoulder resection the tip broke off at the beginning of the surgery.The broken off piece has been retrieved from 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.No further information received.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-8550fot (laser marked with 47682018) was received for investigation.Circumferential marks were noted to have been worn into the outer diameter of the inner tube.Chipping was observed along the corners of the outer tube hood.The observed condition is most likely the result of user applied mechanical forces to device during use, such as through prying/leveraging against bone and/or hard tissue.

• Brand Name: BUR,OVAL,FLUSHCUT,12 FLUT, 5.5MMX 13CM
• Common Device Name: BURR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11627280
• Report Number: 1220246-2021-02839
• Device Sequence Number: 3015631
• Product Code: GFF
• UDI-Device Identifier: 00888867044036
• UDI-Public: 00888867044036
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2021

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 Expiration Date: 07/31/2025
• Device Model Number: BUR,OVAL,FLUSHCUT,12 FLUT, 5.5MMX 13CM
• Device Catalogue Number: AR-8550FOT
• Device Lot Number: 11441754
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 04/07/2021
• Supplement Report FDA Received Date: 06/09/2021
• Patient Sequence Number: 1