MAUDE Adverse Event Report: ARTHREX, INC. SABRE, CURVED 4.0MM X 13CM; SAW BLADE

Model Number	SABRE, CURVED 4.0MM X 13CM
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2023
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
It was reported that during an arthroscopy of the ankle joint metal abrasion was detected in the joint.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a different device (ar-8400cds).It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
This report is being submitted to provide additional information in b5, h3, h6: type of investigation, investigation findings, investigation conclusions, and h10, and updated information in g1, g3.Since the complaint device was not returned, a physical evaluation of the device was not performed.However, the reported event is not confirmed without the device being returned or any photo provided.The most likely cause of the reported event is a user error.Per dfu-0215-eo at revision 1.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.
Event or Problem Description
Additional information received: it was confirmed that all fragments were flushed out of the patient.

• Brand Name: SABRE, CURVED 4.0MM 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: 16973078
• Report Number: 1220246-2023-06773
• Device Sequence Number: 15077938
• Product Code: GFA
• UDI-Device Identifier: 00888867043527
• UDI-Public: 00888867043527
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 06/13/2024

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: SABRE, CURVED 4.0MM X 13CM
• Device Catalogue Number: AR-8400CSR
• Device Lot Number: 15065824
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2023
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 05/22/2023
• Supplement Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2023
• 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
• Patient Sex: Unknown