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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH NEPHEW, INC.; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBO

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SMITH NEPHEW, INC.; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBO Back to Search Results
Model Number 210439
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/01/2022
Event Type  malfunction  
Event Description
Smith and nephew drill bit 2.0 used on operative field broke while in use.Device removed from field.No harm to the patient.
 
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Brand Name
NA
Type of Device
APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBO
Manufacturer (Section D)
SMITH NEPHEW, INC.
150 minuteman road
andover MA 01810
MDR Report Key15814756
MDR Text Key303834689
Report Number15814756
Device Sequence Number1
Product Code KTT
UDI-Device Identifier03596010102560
UDI-Public(01)03596010102560
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 11/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number210439
Device Catalogue Number210439
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/03/2022
Event Location Hospital
Date Report to Manufacturer11/17/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/17/2022
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age18250 DA
Patient SexFemale
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