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

Model Number SHAVER HP, APSII, HAND CONTROL

Device Problems Temperature Problem (3022); Excessive Heating (4030)

Patient Problem Insufficient Information (4580)

Event Date 05/19/2022

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 05/19/2022, it was reported by a sales representative via sems that an ar-8330h shaver started burning.This occurred during an unspecified procedure with no additional information provided.Additional information requested.

Manufacturer Narrative

Complaint not confirmed.Based on the event description, "an ar-8330h shaver started burning", testing was initiated to replicate the customer's complaint by operating the device under worst case scenario conditions utilizing international electrotechnical commission (iec) bs en 60601-1:2006+a2:2021 standard (medical electrical equipment-general requirements for basic safety and essential performance), as the reference point for maximum allowable temperature.A flir (forward looking infrared) thermal camera was used to visually monitor the handpiece body temperature changes throughout the testing using worst case conditions.After running the hand piece dry at different speeds and alternating between modes for a total of 10 minutes, the hand piece body temperature gradually increased from ¿ 24°c to ¿ 40°c.Per table 23 - allowable maximum temperatures for me equipment parts that are likely to be touched found in the bs en 60601-1 standard, the maximum allowable temperature is 48 °c.Therefore, this device is 8°c below the allowable maximum temperature.After the temperature testing, the handpiece was tested per wi-000100858 (handpiece evaluation and disassembly procedure).All functional tests passed all specifications and documented in form-(b)(4).Based all the test results, the complaint is not confirmed.Reference attachment, "mdr ar-8330h (b)(6) testing and iec 60601 standard_table 23".

• Brand Name: SHAVER HP, APSII, HAND CONTROL
• 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: 14603381
• MDR Text Key: 295799098
• Report Number: 1220246-2022-05036
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 00888867043237
• UDI-Public: 00888867043237
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K932699
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SHAVER HP, APSII, HAND CONTROL
• Device Catalogue Number: AR-8330H
• Device Lot Number: 14358158
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2021
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1