MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MOT DR UNIT HNDCONT POWERMAX ELITE; SAW, POWERED, AND ACCESSORIES

Model Number 72200872

Device Problems Mechanical Jam (2983); Output Problem (3005); Protective Measures Problem (3015)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/04/2020

Event Type  malfunction  

Manufacturer Narrative

The reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the product and observed a discolored cord and a broken lanyard.A functional evaluation revealed a jammed motor/ blade stall.The device has been in service for over 5 years, thus any malfunction presented at this point in time would not be related to the manufacture of the product.A complaint history review concluded this was a repeat issue.The complaint was confirmed and the root cause has been associated with a mechanical component failure.Factors that could have contributed to the reported event include corrosion in the gearbox/motor assembly from cleaning and sterilization methods and the chemicals involved over a period of time or one or more of the motor phases shorting out.No containment or corrective actions are recommended at this time.

Event Description

It was reported that during the set up inspection, the mdu had an error message (re start box) and was not working.Backup device was available to complete the procedure.No delay and no patient injuries were reported.Results of investigation revealed that during functional evaluation the motor jammed/ blade stalled which makes it a reportable event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H11.Correction on h6 (patient and device codes added).

• Brand Name: MOT DR UNIT HNDCONT POWERMAX ELITE
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 10817346
• MDR Text Key: 217100103
• Report Number: 1643264-2020-01754
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010618894
• UDI-Public: 03596010618894
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72200872
• Device Catalogue Number: 72200872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Date Manufacturer Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1