MAUDE Adverse Event Report: ARTHREX, INC. PRFL DRL, 5.0MM CMPR FT; DRILL BIT

Model Number	PRFL DRL, 5.0MM CMPR FT
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	07/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via sems that an ar-8750-05 profile drill was overheating and burning bone with use.This occurred during a diaphysectomy of proximal tibia procedure on (b)(6) 2023.No piece broke off inside the patient.The procedure was completed successfully.Additional information has been requested.
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
The complaint allegation is not confirmed.The complaint allegation of burning is unclear from the image submitted for evaluation.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause is attributed to misuse due to prying/leveraging the device during use.

• Brand Name: PRFL DRL, 5.0MM CMPR FT
• Common Device Name: DRILL BIT
• 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: 17514582
• Report Number: 1220246-2023-07481
• Device Sequence Number: 5536082
• Product Code: HTW
• UDI-Device Identifier: 00888867263703
• UDI-Public: 00888867263703
• 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): 12/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: PRFL DRL, 5.0MM CMPR FT
• Device Catalogue Number: AR-8750-05
• Device Lot Number: 1392252
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2023
• Supplement Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 08/11/2023
• Supplement Report FDA Received Date: 12/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown