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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. PERCUTANEOUS GUIDE BOLT ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 71631024
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/24/2018
Event Type  malfunction  
Event Description
It was reported that the piece broke because the surgeons, during the tightening procedure, used too much force and it broke. There was a delay of between 30 minutes and 1 hour, there was no backup device available and no patient injuries were reported.
 
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Brand NamePERCUTANEOUS GUIDE BOLT
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer Contact
sarah freestone
1450 brooks road
memphis, TN 38116
0148276373
MDR Report Key8181313
MDR Text Key130907818
Report Number1020279-2018-02838
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K122170
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/24/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number71631024
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/26/2018
Was Device Evaluated by Manufacturer? No
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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