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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); Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
H10: internal complaint reference number: (b)(4).
 
Event Description
It was reported that the mdu had a blade stall error and overheating of the housing.The deficiency was observed while performing the investigation for the device; therefore, there was no patient involvement.
 
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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
Manufacturer (Section G)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key18563317
MDR Text Key333472950
Report Number1643264-2024-00048
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
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/14/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number72200616
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/01/2023
Is the Reporter a Health Professional? No
Date Manufacturer Received02/13/2024
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 Unknown
Patient Sequence Number1
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