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

Model Number 72200872

Device Problem Unintended Power Up (1162)

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

Event Date 08/12/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that a mot dr unit will not shut off and was suddenly running without operation.No case reported; therefore, there was no patient involvement.

Manufacturer Narrative

H10: internal complaint reference: case-(b)(4).H6: 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 and no issues were noted.Mdu would start and stop running each time the housing was slightly shaken.Cause of intermittent start/stop is a corroded right button assembly.Mdu also fails intermittently for hand piece error when plugged into the control unit.The complaint was confirmed and the root cause has been determined to be corrosion of the right button assembly.Factors that could have contributed to the event include a buildup of corrosion/debris around the button assembly from cleaning chemical fluid ingression over time.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.No containment or corrective actions are recommended at this time.

• 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: 12432342
• MDR Text Key: 270078421
• Report Number: 1643264-2021-02295
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/05/2021

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 Model Number: 72200872
• Device Catalogue Number: 72200872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Initial Date Manufacturer Received: 08/17/2021
• Initial Date FDA Received: 09/07/2021
• Supplement Dates Manufacturer Received: 10/04/2021
• Supplement Dates FDA Received: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1