MAUDE Adverse Event Report: ARTHREX, INC. BUR,OVAL,FLUSHCUT,RETR,8 FLUT,5.0MMX13C; BURR, SURGICAL

Model Number	BUR,OVAL,FLUSHCUT,RETR,8 FLUT,5.0MMX13C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, that during a rotator cuff surgery, the burr tip broke off.The broken part of the device was removed from the patient with an instrument retriever.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with another shaver.It was not necessary to switch the surgical technique or do a second surgery.Update, khe 19-apr-2023, 2 original packed devices were received.
Additional Manufacturer Narrative
The complaint is confirmed.Visual evaluation of the photograph of an alleged ar-8500rfoe attached to the complaint.It is inferred, that the inner tube tip detached from the shaft at the distal end.Cause is undetermined.
Additional Manufacturer Narrative
Corrected information.The device investigation has been updated.The complaint is confirmed.Two packaged ar-8500rfoe, batch 14635643, were received for investigation.The visual evaluation noted poor weld quality.The weld line is incomplete and visible with magnification.Visual evaluation of the photograph of an alleged ar-8500rfoe attached to the complaint.It is inferred that the inner tube tip breaks off during use at the weld location.This is a known manufacturing issue; the cause is attributed to the supplier process.Refer to ncr-22516.
Additional Manufacturer Narrative
Additional information: h6 the complaint is confirmed.Two packages ar-8500rfoe, batch 14635643, were received for investigation.The visual evaluation noted poor weld quality.The weld line is incomplete and visible with magnification.Visual evaluation of the photograph of an alleged ar-8500rfoe attached to the complaint.It is inferred that the inner tube tip breaks off during use at the weld location.This is a known manufacturing issue; the cause is attributed to the supplier process.Refer to ncr-22516.

• Brand Name: BUR,OVAL,FLUSHCUT,RETR,8 FLUT,5.0MMX13C
• 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: vik bajnath ; 8009337001
• MDR Report Key: 16837808
• Report Number: 1220246-2023-06609
• Device Sequence Number: 18029285
• Product Code: GFF
• UDI-Device Identifier: 00888867259782
• UDI-Public: 00888867259782
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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,Followup
• Report Date (Section B): 10/02/2023

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,5.0MMX13C
• Device Catalogue Number: AR-8500RFOE
• Device Lot Number: 14635643
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2023
• Supplement Date Received by Manufacturer: 03/29/2023; 03/29/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 07/25/2023; 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2021
• 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