MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PLATINUM HANDPIECE; SAW, POWERED, AND ACCESSORIES

Catalog Number 72205321

Device Problems Mechanical Problem (1384); Overheating of Device (1437)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2023

Event Type  malfunction  

Event Description

It was reported that during set up the platinum handpiece was not oscillating correctly.There was no delay and a back-up device was available.There was no patient involvement.

Manufacturer Narrative

H10: internal complaint reference:(b)(4).H3, h6: the reported device was received for evaluation.A visual inspection revealed a discolored cable.Discolored cable is a cosmetic issue that does not affect device functionality and it is not related to the alleged failure.A functional evaluation was performed on the returned device and found a blade stall error and overheating of the housing.Further evaluation revealed the drive fork was stiff when rotated.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause has been associated with a mechanical component failure.Factors that could have contributed to the reported failure include a blade stall condition that will result in increased current draw from the control unit which will heat the motor and hand piece housing.This could be the result of gearbox corrosion caused by cleaning and sterilization methods and the chemicals involved.No containment or corrective actions are recommended at this time.

• Brand Name: PLATINUM HANDPIECE
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18968209
• MDR Text Key: 338484354
• Report Number: 1643264-2024-00202
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 00885556786918
• UDI-Public: 885556786918
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/25/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 72205321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2023
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1