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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. SVCE,MOT DR UNIT, HNDCONT POWERMAX ELITE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Catalog Number 72200872S
Device Problem Electrical Shorting (2926)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/06/2017
Event Type  Malfunction  
Event Description

It was reported the powermax elite mdu hand control is shorting out. A back up device was utilized to complete the procedure. No patient injury or complications were reported.

 
Manufacturer Narrative

The reported complaint could not be confirmed. Product did not present any faults during functional testing. At no time did mdu malfunction. All functions perform as expected.

 
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Brand NameSVCE,MOT DR UNIT, HNDCONT POWERMAX ELITE
Type of DeviceINSTRUMENT, 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 drive
austin, TX 78735
5123585706
MDR Report Key6430952
MDR Text Key71064588
Report Number1643264-2017-00163
Device Sequence Number1
Product Code HWE
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/18/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/24/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number72200872S
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/10/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/09/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/25/2016
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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