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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FEMORAL NAIL, RIGHT T2 GTN Ø8X380 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL FEMORAL NAIL, RIGHT T2 GTN Ø8X380 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 18510838S
Device Problems Material Deformation (2976); Material Twisted/Bent (2981)
Patient Problem No Information (3190)
Event Date 04/16/2019
Event Type  Injury  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
It was reported that patient was treated with a stryker gtn2 nail on (b)(6) 2018 after femoral fracture. After 4 months, with normal load, it has been determine that the nail has bent.
 
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Brand NameFEMORAL NAIL, RIGHT T2 GTN Ø8X380 MM
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer Contact
kevin smith
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8601225
MDR Text Key144796933
Report Number0009610622-2019-00244
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K101438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number18510838S
Device Lot NumberK680335RA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/08/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/16/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/14/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/10/2019 Patient Sequence Number: 1
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