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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FEMORAL NAIL PF, RIGHT T2 ALPHA FEMUR ANTEGRADE Ø11X400MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL FEMORAL NAIL PF, RIGHT T2 ALPHA FEMUR ANTEGRADE Ø11X400MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 2337-1140S
Device Problem Difficult to Insert (1316)
Patient Problem Pulmonary Embolism (1498)
Event Date 07/01/2019
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: "patient was (b)(6) years old male, bmi 24. 2, no significant medical history and non-smoker. The injury was due to motor vehicle accident, right femur shaft fracture classified as 32-a3, closed type. During surgery, the right femur was reammed 2 mm over and the nail was impossible to be applied. There was a fracture in the distal femur after multiple tries. The femur 11x*400 t2 alpha femoral nail pf was removed and a regular t2 nail was applied with the same dimensions with no complications. Patient had pulmonary embolism the day of surgery and was discharged 4 days after surgery with no complications. He is 149 days after surgery with a fracture that is healed about 5 months postoperatively. " additionally reported by rep: "due to the type of fracture patient sustained the 11x*400 t2 alpha femoral nail pf could not be inserted therefore the surgeon decided to remove it and install regular t2. The t2 alpha nail did not create or contributed to any additional intra operative fractures. " rep also indicated that the surgeon used reamers from zimmer.
 
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Brand NameFEMORAL NAIL PF, RIGHT T2 ALPHA FEMUR ANTEGRADE Ø11X400MM
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
D-24232
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
D-24232
Manufacturer Contact
kevin smith
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key9998524
MDR Text Key192180419
Report Number0009610622-2020-00173
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K191271
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 04/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number2337-1140S
Device Catalogue Number23371140S
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/11/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 04/24/2020 Patient Sequence Number: 1
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