MAUDE Adverse Event Report: ARTHREX, INC. BUR,OVAL,CLEARCUT,8 FLUT,5.0MMX 13CM; BURR,SURGICAL

Model Number	BUR,OVAL,CLEARCUT,8 FLUT,5.0MMX 13CM
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a rotator cuff surgery the little plastic/acrylic piece detached from the burr and stayed inside of the patient.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.
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 allegation is not confirmed.Visual evaluation identified that the device returned is not the same as the allegation reported.The customer returned the wrong device, and the investigation cannot be performed.Functional testing was not performed because the wrong device was returned.No problem found.

• Brand Name: BUR,OVAL,CLEARCUT,8 FLUT,5.0MMX 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: 17839744
• Report Number: 1220246-2023-08024
• Device Sequence Number: 17989339
• Product Code: GFF
• UDI-Device Identifier: 00888867043756
• UDI-Public: 00888867043756
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 10/21/2024

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,CLEARCUT,8 FLUT,5.0MMX 13CM
• Device Catalogue Number: AR-8500COE
• Device Lot Number: 15061514
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2023
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2023
• 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