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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 Problems Overheating of Device (1437); Self-Activation or Keying (1557)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/12/2013
Event Type  malfunction  
Manufacturer Narrative
Investigation of the returned product failed functional tests with blade stall error.The motor/gearbox pn: 91000516 locked up from saline leak to housing.Motor is extremely corroded and cannot be removed from housing.(b)(4).
 
Event Description
During a hip arthroscopy procedure the motor drive unit, hand cntrl, pwrmx el overheated.The shaver handpiece began to operate on its own and became very hot on the surgical field.
 
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Brand Name
MOTOR DRIVE UNIT, HAND CNTRL, PWRMX EL
Type of Device
SAW, 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
150 minuteman road
andover, MA 01810
5123585706
MDR Report Key4933089
MDR Text Key22658134
Report Number1643264-2015-00052
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 Health Professional
Report Date 07/22/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2015
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? Device Returned to Manufacturer
Date Returned to Manufacturer08/26/2013
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/22/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/10/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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