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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS SMALL T8 TAPERED DR SHAFT - SHORT; SCREWDRIVER
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SMITH & NEPHEW, INC. EVOS SMALL T8 TAPERED DR SHAFT - SHORT; SCREWDRIVER Back to Search Results
Model Number 71175078
Medical Device Problem Code Material Deformation (2976)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 11/16/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Case (b)(4).
 
Event or Problem Description
It was reported during the procedure that the screw drivers are stripped and need to be replaced.The procedure was completed without delay, using the same device.No patient injury or other complications were reported.
 
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Brand Name
EVOS SMALL T8 TAPERED DR SHAFT - SHORT
Common Device Name
SCREWDRIVER
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
MDR Report Key10978790
Report Number1020279-2020-07290
Device Sequence Number2419998
Product Code HXX
UDI-Device Identifier00885556636084
UDI-Public00885556636084
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 09/09/2021
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 Model Number71175078
Device Catalogue Number71175078
Device Lot Number18GUP0024
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/31/2021
Initial Date Received by Manufacturer 11/16/2020
Supplement Date Received by Manufacturer09/08/2021
Initial Report FDA Received Date12/09/2020
Supplement Report FDA Received Date09/09/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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