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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X200MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X200MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 3125-1200S
Device Problems Break (1069); Fracture (1260)
Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369); Ambulation Difficulties (2544); Implant Pain (4561)
Event Date 01/28/2021
Event Type  Injury  
Manufacturer Narrative
Device is not accessible. If additional information becomes available, it will be provided in a supplemental report. Device still implanted in the patient.
 
Event Description
The husband of a patient reported the following: "i am referring to the previous correspondence ((b)(4)) which in summary stated that after an operation, on my wife's left femur, she had begun to suffer from atopic dermatitis. Intervention on (b)(6) 2019 performed at the (b)(6) hospital. Subsequently, the fact that from the metal tests done to my wife, she was not allergic to titanium or the material of the nail, from a certain point of view calmed me, but then after a year ((b)(6) 2021) the nail broke. From asst (b)(6) hospital report i read: "x-ray: unconsolidated existence of pertrochanteric fracture with reverse rim and fatigue fracture of the femoral nail at the level of the cephalic screw. " the patient also reported pain.
 
Manufacturer Narrative
Device is not accessible. If additional information becomes available, it will be provided in a supplemental report. Device still implanted in the patient.
 
Event Description
The husband of a patient reported the following: "i am referring to the previous correspondence ((b)(4)) which in summary stated that after an operation, on my wife's left femur, she had begun to suffer from atopic dermatitis. Intervention on (b)(6) 2019 performed at the (b)(6) hospital. Subsequently, the fact that from the metal tests done to my wife, she was not allergic to titanium or the material of the nail, from a certain point of view calmed me, but then after a year ((b)(6) 2021) the nail broke. From asst (b)(6) hospital report i read: "x-ray: unconsolidated existence of pertrochanteric fracture with reverse rim and fatigue fracture of the femoral nail at the level of the cephalic screw. " the patient also reported pain.
 
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Brand NameTROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X200MM 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
GM D-24232
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM D-24232
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key13560494
MDR Text Key285955481
Report Number0009610622-2022-00062
Device Sequence Number1
Product Code HSB
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 Consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3125-1200S
Device Catalogue Number31251200S
Device Lot NumberK087643
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/31/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/26/2019
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: 02/18/2022 Patient Sequence Number: 1
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