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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REPAIR POWERMAX ELITE MDU HAND CNTRL SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. REPAIR POWERMAX ELITE MDU HAND CNTRL SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 72200616R
Device Problem Sticking (1597)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/11/2018
Event Type  malfunction  
Event Description
It was reported that mdu has sticky buttons. No back up device was available. No patient injury was reported.
 
Manufacturer Narrative
The device was received for evaluation. There was a relationship found between the returned device and the reported incident. A visual inspection was performed and the surface of the housing is damaged. It appears that the metal surface of the hand piece has been eaten away by a corrosive chemical, possibly due to harsh sterilization procedures. The product's ifu states the following: immerse the handpiece and soak for a minimum of five minutes using a neutral ph enzymatic detergent. Complaint of sticking buttons were confirmed. Product failed functional testing when the reverse button failed to function. Cause of button malfunction is an extremely corroded button assembly. The complaint was confirmed and the root cause has been determined to be corrosion of the reverse button assembly. Factors that could have contributed to the event include a buildup of corrosion/debris around the button assembly from cleaning chemical fluid ingression over time. 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.
 
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Brand NameREPAIR POWERMAX ELITE MDU HAND CNTRL
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
MDR Report Key7494791
MDR Text Key107693808
Report Number1643264-2018-00347
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
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 05/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number72200616R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/27/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/24/2018
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 Reuse

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