MAUDE Adverse Event Report: ARTHREX, INC. SABRE, 3.8MM X 13CM; SAW BLADE

Model Number	SABRE, 3.8MM X 13CM
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an autocart surgery the plastic has melted on the inside of the shaft.There was no harm for patient, operator or third party reported.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.20-nov-2023 update dw: further information were provided that nothing of the device broke off and that after the surgery the issue with the molten plastic was noticed after the surgery.
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.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint is confirmed based on the customer-provided photo, which displays the ar-8380sr sabre, 3.8 mm x 13 cm inner tube (shaft) with residues of melted plastic from the shrink tubing.The method of bone preparation employed during the procedure, as well as the bone quality encountered, was not provided.The picture shows that the event is consistent with thermal burn.Per dfu-0215-7 at revision 0.Section f.Precautions.1.Surgeons are advised to review the product specific surgical technique prior to performing any surgery.Arthrex provides detailed surgical techniques in print, video, and electronic formats.The arthrex website also provides detailed surgical technique information and demonstrations.Or, contact your arthrex representative for an onsite demonstration.9.Irreversible damage to all devices will result if they are run without the flow of irrigation (dry).10.Running the device without the flow of irrigation (dry) will cause the device to excessively heat and may cause a thermal burn.The most likely cause for the reported failure can be attributed to user error of the device running the device without the flow, causing the excessive heat.

• Brand Name: SABRE, 3.8MM 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: emily shafer ; 8009337001
• MDR Report Key: 18340775
• Report Number: 1220246-2023-09429
• Device Sequence Number: 15138477
• Product Code: GAT
• UDI-Device Identifier: 00888867043398
• UDI-Public: 00888867043398
• 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): 12/03/2024

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, 3.8MM X 13CM
• Device Catalogue Number: AR-8380SR
• Device Lot Number: 15022297
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2023
• Supplement Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown