MAUDE Adverse Event Report: ARTHREX, INC.; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Device Problems Overheating of Device (1437); Smoking (1585); Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Date 03/04/2022

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

On (b)(6) 2022, it was reported by a distributor via sems that while using the ar-8305 shaver console, the handpiece started to heat almost smoking, and displayed error code c34.This was discovered during use in a procedure.Requested additional information.Additional information provided (b)(6) 2022: it was reported by a distributor via email that while using the ar-8305 shaver console, the handpiece was heating the surgeon hand, and displayed error code c34.This was discovered during use in a rotator cuff repair procedure on (b)(6) 2022.The case was completed by changing the handpiece and the burr.After the case was completed, the handpiece was tested outside the sterile field by the nurse, and the handpiece heated and started to have a little bit of smoke.The part number and serial number of the handpiece is not available.

Manufacturer Narrative

The complaint is not confirmed.The reported device was not returned for investigation.No pictures were provided.However, per the event description is inferred that the cause for the reported failure is attributed to wear and tear: the c34 error is an indication of an overcurrent above 7.0a for 3 seconds.An overcurrent condition can be caused by a shaver handpiece motor that has reached end of life.The increased temperature on the shaver handpiece is also consistent with end of life.Per synergy and adapteur power system¿ ii (aps ii) shaver handpieces direction for use, dfu-0154-5 section f.Inspection and maintenance, the user is instructed to inspect the device for excessive heating, and the user is informed that the device may have reached end of life if critical errors or abnormal temperature are noticed.

• Brand Name: UNK
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• 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: 13995371
• MDR Text Key: 298280854
• Report Number: 1220246-2022-04707
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K932699
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 06/07/2023

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/16/2022
• Initial Date FDA Received: 04/04/2022
• Supplement Dates Manufacturer Received: 03/16/2022
• Supplement Dates FDA Received: 06/07/2023
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1