MAUDE Adverse Event Report: ARTHREX, INC. SAW ATTACHMENT-SAGITTAL; POWERED SURG ORTHOPEDIC INSTR

Model Number	SAW ATTACHMENT-SAGITTAL
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2023
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
On 11/28/2023, it was reported by a sales representative via sems-06411874 that an ar-400sag drillsaw sports 400 system was not moving as rapidly as it should and would not cut.This occurred during a case, with no effect on the patient.There was no additional information provided, and additional information has been requested.
Additional Manufacturer Narrative
The complaint allegation is confirmed.One unpackaged ar-400sag serial/batch number (b)(6) was received for investigation.No functional testing was performed for this device due to no mating part.Visual evaluation revealed a worn-out crew at the retaining claw.Signs of wear and tear, as well as scratch marks on the head and body of the device.The most likely cause of the reported failure is the use error of mishandling the device.

• Brand Name: SAW ATTACHMENT-SAGITTAL
• Common Device Name: POWERED SURG ORTHOPEDIC INSTR
• 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: 18394074
• Report Number: 1220246-2023-09610
• Device Sequence Number: 11496057
• Product Code: HWE
• UDI-Device Identifier: 00888867223424
• UDI-Public: 00888867223424
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/19/2024

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 Model Number: SAW ATTACHMENT-SAGITTAL
• Device Catalogue Number: AR-400SAG
• Device Lot Number: 15071594
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2023
• Supplement Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 12/26/2023
• Supplement Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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