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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
Catalog Number 71631140
Device Problem Insufficient Information (3190)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/01/2018
Event Type  malfunction  
Event Description
It was reported that during surgery the guide bolt wrench head snapped off inside the guide bolt.All pieces accounted for.Delay of over 2 hours reported.No injury reported.Procedure finished with competitor device.
 
Manufacturer Narrative
The associated guide bolt and guide bolt wrench were returned and evaluated.A visual inspection found that the hex head of the wrench has sheared off; the broken piece was returned with the device.The hex feature can break if the torque applied to the driver exceeds the material strength.The device was manufactured in 2007.The guide bolt was stuck inside the drill guide and could not be removed.The date of manufacture is unknown for this part.Our investigation did not determine a specific cause of the stated failure.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.
 
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Brand Name
GUIDE BOLT WRENCH
Type of Device
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key8098942
MDR Text Key128193482
Report Number1020279-2018-02561
Device Sequence Number1
Product Code HSB
UDI-Device Identifier03596010560469
UDI-Public03596010560469
Combination Product (y/n)N
PMA/PMN Number
K122170
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number71631140
Device Lot Number07CM16174
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2018
Date Manufacturer Received11/02/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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