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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL U-BLADE SET, TI GAMMA3® Ø10.5X105MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL U-BLADE SET, TI GAMMA3® Ø10.5X105MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 3066-0105S
Device Problem Material Twisted/Bent (2981)
Patient Problems Failure of Implant (1924); Hip Fracture (2349)
Event Date 09/21/2021
Event Type  Injury  
Manufacturer Narrative
The device will not be returned. If additional information becomes available, it will be provided in a supplemental report.
 
Event Description
As reported: cutout of proximal femoral restoration with gamma3 u-blade, u-blade is bent, removal difficult.
 
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Brand NameU-BLADE SET, TI GAMMA3® Ø10.5X105MM
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
marilyne chaumont
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key12647600
MDR Text Key277099349
Report Number0009610622-2021-00762
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K200869
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3066-0105S
Device Catalogue Number30660105S
Device Lot NumberK0CDA10
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/24/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/07/2021
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: 10/18/2021 Patient Sequence Number: 1
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