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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. MOTOR DRIVE UNIT, HAND CNTRL, PWRMX EL SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 72200616
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/16/2017
Event Type  malfunction  
Manufacturer Narrative
One powermax elite motor drive unit, part number 72200616 was received on august 23, 2017 and confirmed to be serial number (b)(4). There was a relationship found between the returned device and the reported incident. Complaint of ¿keeps running¿ was confirmed. The mdu failed for hand piece error. Cause of error is a stuck button. The forward direction button was depressed, stuck in the ¿on¿ position due to extreme corrosion. Button spring was completely rusted and collapsed. Collapsed button is the cause of ¿keeps running¿ stated in complaint. Mdu is over 5 years old. Mdu passed functional testing after button spring was unstuck. No containment or corrective actions are recommended at this time. The complaint investigation has concluded that the device has exceeded its recommended service life limit and has succumbed to expected wear and tear.
 
Event Description
According to the customer the device kept running during the procedure. No patient or user injury was reported. A backup device of the same kind was available.
 
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Brand NameMOTOR DRIVE UNIT, HAND CNTRL, PWRMX EL
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
james gonzales
7000 w. william cannon drive
austin, TX 78735
MDR Report Key6820115
MDR Text Key83747133
Report Number1643264-2017-00502
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 user facility
Reporter Occupation
Type of Report Initial
Report Date 08/25/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/25/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number72200616
Device Lot NumberAAL44562
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/23/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/17/2017
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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