MAUDE Adverse Event Report: ARTHREX, INC. SABRE, 4.0MM X 13CM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number	SABRE, 4.0MM X 13CM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/23/2023
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 prior to a surgery the customer had difficulties to attach the shaver blade onto the handpiece.The customer the used betadine which allowed the attachment to slide enough to be put it on the handpiece.The surgery was then finished successfully however at the end of the surgery when the surgeon removed from it the portal (incision site shoulder) the blade broke off.The customer further reported that the point of breakage was from the inside to the outside and appeared to be as it had been twisted off.No further information received.

• Brand Name: SABRE, 4.0MM X 13CM
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• 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: 16385424
• Report Number: 1220246-2023-06298
• Device Sequence Number: 14851080
• Product Code: GFA
• UDI-Device Identifier: 00888867043633
• UDI-Public: 00888867043633
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• Report Date (Section B): 02/16/2023

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, 4.0MM X 13CM
• Device Catalogue Number: AR-8400SR
• Device Lot Number: 14985111
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 02/16/2023
• Date Device Manufactured: 07/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown