MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MOT DR UNIT HNDCONT POWERMAX ELITE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number 72200872

Device Problem Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that the motor drive unit was getting hot.No case reported; therefore, there was no patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

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 exterior of product and no physical damage was observed.Mdu failed functional tests with hand piece overload when power cord was bent or twisted.Power cord assembly grew warm during testing.After troubleshooting, the cause of the overheating was observed to be a defective power cord assembly.A visual inspection was performed on the power cords external covering and no physical damage was observed.It was determined that the power cord has shorted and/or opens internal wiring.Motor and hall board were tested and passed functional testing.The complaint investigation has concluded that this unit has succumbed to physical damage to power cord.Factors which can contribute to a shorted power cord include rolling a heavy cart over the cord or excessive bending of the cord.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.

• Brand Name: MOT DR UNIT HNDCONT POWERMAX ELITE
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 9302758
• MDR Text Key: 177235695
• Report Number: 1643264-2019-00774
• Device Sequence Number: 1
• Product Code: HWE
• 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,health
• Type of Report: Initial,Followup
• Report Date: 12/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72200872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2019
• Date Manufacturer Received: 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1