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

Model Number SABRE, 4.0MM X 13CM

Device Problems Break (1069); Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Date 01/23/2023

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 309650645
• Report Number: 1220246-2023-06298
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 00888867043633
• UDI-Public: 00888867043633
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/30/2023
• Date Device Manufactured: 07/26/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1