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

Model Number	SAW ATTACHMENT - SAGITTAL
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2021
Type of Reportable Event	Malfunction
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.Event description: it was reported that during the surgery the sawblade came easily loose in the device, because there is something wrong with the button of the device.The reported event was confirmed.The manufacturers evaluation revealed a sticking clamping system.The most likely cause of this condition is user error due to the manufacturers evaluation revealed a sticking clamping system.
Event or Problem Description
It was reported that during the surgery the sawblade came easily loose in the device, because there is something wrong with the button of the device.No part of the device broke off.There was no harm or adverse event for patient, operator or third party reported.The surgery was finished successfully with the same device, but the error was described as inconvenient.It was not necessary to switch the surgical technique or do a second surgery.

• 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: jared engle ; 8009337001
• MDR Report Key: 19391465
• Report Number: 1220246-2024-03839
• Device Sequence Number: 6786761
• Product Code: HWE
• UDI-Device Identifier: 00888867100251
• UDI-Public: 00888867100251
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/24/2024

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-300SAG
• Device Lot Number: 10123934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown