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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER CORP. STRYKER SUPRACONDYLAR NAIL (SCN) SYSTEM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER CORP. STRYKER SUPRACONDYLAR NAIL (SCN) SYSTEM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Failure of Implant (1924); Pain (1994)
Event Date 09/11/2018
Event Type  malfunction  
Event Description
We have experienced four cases where the distal locking screw of the stryker supracondylar nail (scn) system disengages from the bone and nail. In all four cases the screws have backed out to the point that they were prominent and painful thereby necessitating surgical removal. Patient 1 - left distal femur fracture s/p retrograde intramedullary nailing using stryker scn last year. Prominent screw removal 5 months later. Patient 2 - left distal femur fracture s/p multiple surgeries with retrograde intramedullary nailing of nonunion using stryker scn last year. Prominent screw removal one month later. Patient 3 - right distal femur fracture s/p retrograde intramedullary nailing using stryker scn earlier this year. Prominent screw removal 5 months later. Patient 4 - left distal femur fracture intramedullary nailing using stryker scn earlier this year. Prominent screw removal 4 months later. Manufacturer response for supracondylar nail, stryker supracondylar nail (scn) system (per site reporter).
 
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Brand NameSTRYKER SUPRACONDYLAR NAIL (SCN) SYSTEM
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER CORP.
2825 airview blvd.
portage MI 49002
MDR Report Key8084239
MDR Text Key127561683
Report Number8084239
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2018
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/07/2018
Device Age4 MO
Event Location Hospital
Date Report to Manufacturer11/19/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 11/19/2018 Patient Sequence Number: 0
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