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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL U-BLADE SET, TI GAMMA3 10.5X105MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL U-BLADE SET, TI GAMMA3 10.5X105MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 3066-0105S
Device Problems Positioning Failure (1158); Migration (4003)
Patient Problems Failure of Implant (1924); Perforation (2001)
Event Date 07/06/2020
Event Type  Injury  
Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
 
Event Description
As reported: "during lag screw did not slide, and it penetrated the femoral head. The surgeon it could be due to the set screw. ".
 
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Brand NameU-BLADE SET, TI GAMMA3 10.5X105MM
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
sharon rivas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key10348101
MDR Text Key202881729
Report Number0009610622-2020-00418
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K043431
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 11/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2021
Device Model Number3066-0105S
Device Catalogue Number30660105S
Device Lot NumberK060B87
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/22/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/27/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/06/2016
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: 07/30/2020 Patient Sequence Number: 1
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