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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FEMORAL NAIL, RIGHT T2 GTN Ø13X340 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL FEMORAL NAIL, RIGHT T2 GTN Ø13X340 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 18511334S
Device Problem Crack (1135)
Patient Problem No Information (3190)
Event Date 03/23/2018
Event Type  Injury  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
There were femoral bone trunk and pelvic fracture. Reaming to 14. 5 mm and inserting 13 mm nail. There was a gap of about 1 cm after nail insertion, so did a compression. There was disappears a gap almost. Although the reduction was also good, it turned out that it broke in a large vertical crack shape starting from the compression screw part. It was thought that fixing for was insufficient by only nail and two cables were wound. At that time it took about 1 hour.
 
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Brand NameFEMORAL NAIL, RIGHT T2 GTN Ø13X340 MM
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
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7444278
MDR Text Key105962885
Report Number0009610622-2018-00178
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K101438
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 10/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2020
Device Catalogue Number18511334S
Device Lot NumberK049F3F
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/19/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/25/2015
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: 04/19/2018 Patient Sequence Number: 1
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