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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYNAMOMETRIC WIRE TENSIONER; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
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SMITH & NEPHEW, INC. DYNAMOMETRIC WIRE TENSIONER; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT Back to Search Results
Catalog Number 103101
Medical Device Problem Code Unstable (1667)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 03/14/2021
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that, when checking a dynamometric wire tensioner before case in central sterile processing, it was no longer holding tension.As incident occurred before the procedure, there was no patient involvement.
 
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Brand Name
DYNAMOMETRIC WIRE TENSIONER
Common Device Name
APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
MDR Report Key11627299
Report Number1020279-2021-02770
Device Sequence Number3279838
Product Code KTT
UDI-Device Identifier08033201842065
UDI-Public8033201842065
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
K093047
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 10/13/2021
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
Operator of Device Health Professional
Device Catalogue Number103101
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/26/2021
Initial Date Received by Manufacturer 03/14/2021
Supplement Date Received by Manufacturer10/12/2021
Initial Report FDA Received Date04/07/2021
Supplement Report FDA Received Date10/13/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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