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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GUIDE BOLT WRENCH ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. GUIDE BOLT WRENCH ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 71631140
Device Problems Break (1069); Material Separation (1562)
Patient Problems Failure of Implant (1924); No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/02/2020
Event Type  Injury  
Event Description
It was reported that during surgery, while trying to take the guide bold out, additional force was applied to the driver and device broke while inside the patient. A delay greater than 30 minutes was reported and procedure concluded without injuries and with a back-up device from a competitor. The patient outcome is unknown.
 
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Brand NameGUIDE BOLT WRENCH
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key10292683
MDR Text Key199439191
Report Number1020279-2020-03316
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122170
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 08/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71631140
Device Catalogue Number71631140
Device Lot Number08HM14793
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/05/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/20/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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