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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 7/16 GUIDE BOLT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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SMITH & NEPHEW, INC. 7/16 GUIDE BOLT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 71674071
Medical Device Problem Codes Failure to Align (2522); Material Deformation (2976)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 08/20/2021
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that a drill guide handle is warped and its targeting is off and that a 7/16 guide bolt is cross-threaded and does not attach properly.As this was noticed upon field inspection, there was not patient involvement.
 
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Brand Name
7/16 GUIDE BOLT
Common Device Name
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
MDR Report Key12456448
Report Number1020279-2021-06815
Device Sequence Number17483018
Product Code HSB
UDI-Device Identifier03596010560643
UDI-Public03596010560643
Combination Product (Y/N)N
Initial Reporter StateNV
Initial Reporter CountryUS
PMA/510(K) Number
K122170
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 10/19/2021
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 Number71674071
Device Catalogue Number71674071
Device Lot Number20BM07998
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/15/2021
Initial Date Received by Manufacturer 08/20/2021
Supplement Date Received by Manufacturer10/19/2021
Initial Report FDA Received Date09/10/2021
Supplement Report FDA Received Date10/19/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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