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 Temperature Problem (3022)

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

Event Date 12/11/2014

Event Type  malfunction  

Event Description

It was reported the device gets too hot.

• 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 w. william cannon dr.; austin, TX 78735
• MDR Report Key: 7003540
• MDR Text Key: 91519163
• Report Number: 1643264-2017-01455
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 11/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2017
• 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?: No
• Date Manufacturer Received: 12/11/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1