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

Catalog Number 72205321

Device Problems Corroded (1131); Overheating of Device (1437); Noise, Audible (3273)

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

Event Type  malfunction  

Manufacturer Narrative

H10: internal complaint reference number: (b)(4).

Event Description

It was reported that the platinum handpiece was getting hot while being used.It is unknown whether the event happened during surgery, if there was patient involvement, if there was a back-up device available or if there was a surgical delay.No further complications were reported.

Manufacturer Narrative

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 a noisy motor was found further evaluation revealed a corroded gearbox.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 was associated with a mechanical component failure.Factors that could have contributed to the 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 can 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.

Manufacturer Narrative

H10: h2: additional information on: b5 & h6.

Event Description

It was reported that during a knee arthroscopy, the platinum handpiece was getting hot while being used.The procedure was completed without surgical delay using a smith and nephew back up device.No further complications were reported.

• 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: 18630154
• MDR Text Key: 334501200
• Report Number: 1643264-2024-00085
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2024

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: 01/31/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2024
• Initial Date FDA Received: 02/02/2024
• Supplement Dates Manufacturer Received: 02/07/2024; 04/08/2024
• Supplement Dates FDA Received: 02/11/2024; 04/11/2024
• 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