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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.0MM SURESHOT SHORT AO DRILL; ORTHOPEDIC STEREOTAXIC INSTRUMENT
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SMITH & NEPHEW, INC. 4.0MM SURESHOT SHORT AO DRILL; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 71692810
Medical Device Problem Code Use of Device Problem (1670)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 03/05/2020
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that during trigen meta nail tibia procedure while drilling a distal a/p hole, the device could drill the cortical on the near side, but could not penetrate to the opposite cortical.The surgeon decided to use a radiolucent drill to complete the procedure, moreover, surgery was delayed for no more than 30 min.No patient injuries were reported.
 
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Brand Name
4.0MM SURESHOT SHORT AO DRILL
Common Device Name
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key9831257
Report Number1020279-2020-00873
Device Sequence Number19017670
Product Code OLO
UDI-Device Identifier03596010648242
UDI-Public03596010648242
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K100107
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 08/23/2021
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 Number71692810
Device Catalogue Number71692810
Device Lot Number71692810
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 03/05/2020
Supplement Date Received by Manufacturer08/22/2021
Initial Report FDA Received Date03/13/2020
Supplement Report FDA Received Date08/23/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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