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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FEMORAL NAIL GT, LEFT T2 ALPHA FEMUR ANTEGRADE Ø10X380MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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STRYKER TRAUMA KIEL FEMORAL NAIL GT, LEFT T2 ALPHA FEMUR ANTEGRADE Ø10X380MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 2331-1038S
Device Problems Break (1069); Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Failure of Implant (1924); Insufficient Information (4580)
Event Date 02/19/2022
Event Type  Injury  
Event Description
As reported: "a priorly implanted t2 alpha antegrade nail was explanted. A gamma nail was used as a replacement. ".
 
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report. Device disposition unknown.
 
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Brand NameFEMORAL NAIL GT, LEFT T2 ALPHA FEMUR ANTEGRADE Ø10X380MM
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 Key13839222
MDR Text Key287528375
Report Number0009610622-2022-00098
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 Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2331-1038S
Device Catalogue Number23311038S
Device Lot NumberK08225ARA
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received06/23/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/23/2020
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: 03/21/2022 Patient Sequence Number: 1
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