MAUDE Adverse Event Report: ARTHREX, INC. BURR, ROUND, 8 FLUTE 5.0MM X 13CM; BURR,SURGICAL

Model Number	BURR, ROUND, 8 FLUTE 5.0MM X 13CM
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2023
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that during an ankle joint surgery the shaver runs with 6800 rotations and then metal abrasion was produced.The metal abrasion was flushed out of the patient.There was no harm for patient, operator or third party.The surgery was finished successfully the same device was used anyway.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h6.Complaint is confirmed.Visual inspection revealed abrasions along the inner face and outer face of the outer shaft.Functional testing was performed by testing the device on multiple settings and no issues were found with the functionality of the device.The most likely cause of the reported failure can be attributed to use error due to prying/leveraging the device while in use.Per dfu-0215 section f.Precautions 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: BURR, ROUND, 8 FLUTE 5.0MM X 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: 18141810
• Report Number: 1220246-2023-08752
• Device Sequence Number: 15449154
• Product Code: GFF
• UDI-Device Identifier: 00888867043879
• UDI-Public: 00888867043879
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 05/16/2024

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: BURR, ROUND, 8 FLUTE 5.0MM X 13CM
• Device Catalogue Number: AR-8500RBE
• Device Lot Number: 15004931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2023
• Supplement Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2022
• 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