MAUDE Adverse Event Report: ARTHREX, INC. SABRE, SJ 3.0MM 7CM; SAW BLADE

Model Number	SABRE, SJ 3.0MM 7CM
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/04/2023
Type of Reportable Event	Serious Injury
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 autocart surgery at the ankle metal debris was produced by the device.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.(b)(6)2023 update dw.Further information were provided that it appears that not all fragments could be retrieved out of the patient.
Additional Manufacturer Narrative
The complaint is confirmed.Visual evaluation noted that it had damage on one side of the edges of the inner tube.Functional testing was not performed due to the damage to the device.The most likely cause for the observed condition is the application of excessive forces/side-loading on the device during use, characterizing abnormal use.Directions for use dfu-0215-eo section f.7 indicate that "excessive "side-loading" on the device during use does not improve cutting performance and in extreme cases will cause irreversible damage to the device.".

• Brand Name: SABRE, SJ 3.0MM 7CM
• 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: vik bajnath ; 8009337001
• MDR Report Key: 17017774
• Report Number: 1220246-2023-06798
• Device Sequence Number: 12554805
• Product Code: GFA
• UDI-Device Identifier: 00888867041974
• UDI-Public: 00888867041974
• 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): 10/18/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SABRE, SJ 3.0MM 7CM
• Device Catalogue Number: AR-7300SR
• Device Lot Number: 14919215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2023
• Supplement Date Received by Manufacturer: 09/06/2023
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2022
• 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