MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MOTOR DRIVE UNIT, HAND CNTRL, PWRMX EL; SAW, POWERED, AND ACCESSORIES

Model Number 72200616

Device Problems Failure to Shut Off (2939); No Apparent Adverse Event (3189)

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

Event Date 05/13/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that the motor drive unit displayed an error message when plugged in and then it would not turn off during the check.No case reported.Therefore; there was no patient involvement.

Manufacturer Narrative

H3, h6: the reported device was received for evaluation.It was determined the device contributed to the reported event.A visual inspection found a discolored cable.A functional evaluation revealed a noisy motor.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 specification upon release for distribution.A complaint history review concluded this was a repeat event.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The complaint of a noisy motor was confirmed, and the root cause was associated with corrosion in the gearbox.Factors that could have contributed to the failure include corrosion in the gearbox/motor assembly from cleaning and sterilization methods and the chemicals involved over a period of time.The complaints of failure to shut off and error message were not confirmed.Factors that could have contributed to the reported events include a failure of a concomitant device.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.

• Brand Name: MOTOR DRIVE UNIT, HAND CNTRL, PWRMX EL
• 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: 14604892
• MDR Text Key: 301106100
• Report Number: 1643264-2022-00193
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010555472
• UDI-Public: 03596010555472
• 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: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/11/2022

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: 72200616
• Device Catalogue Number: 72200616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/07/2022
• 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