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 Failure to Power Up (1476)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/06/2018

Event Type  malfunction  

Event Description

It was reported that the shaver would not turn off.The procedure was completed with a backup device with no delay or patient injury reported insignificant delay.

Manufacturer Narrative

The device was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection was performed on the product and no issue was observed.Complaint of shaver not turning off could not be reproduced.Product passed functional testing with no faults or errors.All 3 buttons perform as expected.Mdu stopped and started correctly using the buttons and the footswitch.The complaint of shaver not turning off was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.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
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 8099887
• MDR Text Key: 128265805
• Report Number: 1643264-2018-00912
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 03596010618894
• UDI-Public: 03596010618894
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/28/2018

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: 72200872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/07/2018
• Initial Date FDA Received: 11/23/2018
• Supplement Dates Manufacturer Received: 12/27/2018
• Supplement Dates FDA Received: 12/28/2018
• 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