MAUDE Adverse Event Report: ARTHREX, INC. BONE CUTTER,5.5MM X 13CM; SAW BLADE

Model Number	BONE CUTTER,5.5MM X 13CM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021, it was reported by a sales representative via sems that a ar-8550bc bone cutter bent.This occurred during a procedure while in the subacomial space, he was running the device in forward at 8000 rpms when it bent, the device broke after being removed from the patient.No additional information provided.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint confirmed.One unpackaged ar-8550bc was received for investigation.Visual inspection identified that the returned cutter had bent and broken proximal to the hub component.The observed condition is consistent with user applied mechanical forces, such as prying/leveraging against bone and/or hard tissue.No damage was noted to the cutting tip.

• Brand Name: BONE CUTTER,5.5MM X 13CM
• Common Device Name: SAW BLADE
• 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: jared engle ; 8009337001
• MDR Report Key: 19567612
• Report Number: 1220246-2024-06118
• Device Sequence Number: 6963401
• Product Code: GFA
• UDI-Device Identifier: 00888867043930
• UDI-Public: 00888867043930
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/19/2024

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 Expiration Date: 08/31/2026
• Device Model Number: BONE CUTTER,5.5MM X 13CM
• Device Catalogue Number: AR-8550BC
• Device Lot Number: 14223913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2021
• Initial Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2021
• 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