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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 31251180S
Device Problems Break (1069); Fracture (1260)
Patient Problems Injury (2348); No Information (3190)
Event Date 07/26/2019
Event Type  Injury  
Manufacturer Narrative
Device was not returned. If additional information becomes available, it will be provided in a supplemental report. Device disposition unknown.
 
Event Description
As reported: "on 2014 patient underwent surgery following a pertrochanteric fracture of the right femur. Due to pseudarthrosis of the fracture, the nail broke, was removed and a new synthesis was performed on (b)(6)2019. ".
 
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Brand NameTROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125°
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
sharon rivas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8974119
MDR Text Key156900284
Report Number0009610622-2019-00639
Device Sequence Number1
Product Code HSB
UDI-Device Identifier04546540375070
UDI-Public04546540375070
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K034002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 11/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2019
Device Catalogue Number31251180S
Device Lot NumberK0DDBD7
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/29/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/01/2014
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: 09/09/2019 Patient Sequence Number: 1
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