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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MOTOR DRIVE UNIT NON-HAND CNTL PWRMX SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. MOTOR DRIVE UNIT NON-HAND CNTL PWRMX SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 72200616
Device Problems Overheating of Device (1437); Therapeutic or Diagnostic Output Failure (3023); Handpiece (3067)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/05/2019
Event Type  Malfunction  
Event Description

It was reported that the surgeon was performing arthroscopic acromioplasty, whilst using dyonics powermax elite, the handpiece stopped working,they tried to get it to work but it appeared there was a problem with the motor mechanism and handpiece was heating up. No patent injury was reported. It is unknown if there was a procedure delay or a backup device available.

 
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Brand NameMOTOR DRIVE UNIT NON-HAND CNTL PWRMX
Type of DeviceSAW, POWERED, AND ACCESSORIES
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 Key8644298
MDR Text Key146234365
Report Number1643264-2019-00372
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeSF
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/15/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/27/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number72200616
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/15/2019
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 Unkown

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