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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS POWERMAX ELITE SHAVER HANDPIECE; SAW, POWERED, AND ACCESSORIES
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SMITH & NEPHEW, INC. DYONICS POWERMAX ELITE SHAVER HANDPIECE; SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number 72200616
Device Problem Metal Shedding Debris (1804)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/23/2016
Event Type  malfunction  
Event Description
Dr used the dyonics powermax elite shaver handpiece with a regular shaver and had no issues.When he switched over to the 4.0 abrader burr to burr on the bone, metal shavings could be visibly seen within the joint.When he switched from 4.0 to the 5.5 abrader burr, again metal shavings could be visibly seen in the joint.We could not determine if the metal shavings were being caused by a malfunction of the burrs or of the shaver handpiece.Devices: 5.5 abrader burr, 180mm: catalog #72200082, lot #50617643; 4.0 abrader burr, 180mm: catalog #72200080, lot #50979281.
 
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Brand Name
DYONICS POWERMAX ELITE SHAVER HANDPIECE
Type of Device
SAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
7135 goodlett farms pkwy
cordova TN 38016
MDR Report Key6036342
MDR Text Key57716206
Report Number6036342
Device Sequence Number0
Product Code NBH
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 09/23/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number72200616
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/23/2016
Event Location Hospital
Date Report to Manufacturer09/23/2016
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/18/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
THE ARTHREX CONTINUOUS WAVE III ARTHROSCOPY PUMP W
Patient Age50 YR
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