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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FEMORAL NAIL PF, RIGHT T2 ALPHA FEMUR ANTEGRADE 11X380MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL FEMORAL NAIL PF, RIGHT T2 ALPHA FEMUR ANTEGRADE 11X380MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 2337-1138S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Impaired Healing (2378); Post Operative Wound Infection (2446)
Event Date 08/06/2020
Event Type  Injury  
Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available. More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event. The device history record could not be reviewed because the affected lot number was not communicated. If any further information is provided, the investigation report will be updated.
 
Event Description
The manufacturer became aware of a post market clinical follow-up report received from (b)(6), in usa. The title of this report is ¿a retrospective data collection of the treatment of femoral fractures with the femoral nail piriformis fossa (pf) of the t2 alpha femur antegrade gt/pf nailing system¿ which is associated with the stryker ¿t2 alpha femur antegrade gt/pf nailing system¿. This study includes research done on 18 patients (19 cases) requiring surgery between the period march 2019 and october 2019. It was not possible to ascertain specific device details from the report, or to match the events reported with previously reported complaints. Therefore, new complaint was initiated in the system for the post-operative complication mentioned in the report. This product inquiry addresses delayed union due to infection which was resolved by revision. The report states: ¿there were 3 delayed unions, which were defined as the absence of radiographic progression of healing or the instability of a fracture upon clinical examination between 4 and 6 months after injury. One was due to infection of union that was not device related, which was resolved with revision surgery (right femoral intramedullary nail exchange from a t2 femur nail) after 156 days from the initial surgery. Once the nail was exchanged, this patient was no longer being followed for this study. The patient was (b)(6) year-old male, smoker with a bmi of 24. 9, was involved in a motorcycle collision, the injury was to his right femur, fracture was classified as 32-b2 and it was closed type fracture. The initial device used was 11x380 t2 alpha femoral nail pf, and had proximal static transverse locking mode. ¿.
 
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Brand NameFEMORAL NAIL PF, RIGHT T2 ALPHA FEMUR ANTEGRADE 11X380MM
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
kevin smith
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key10538666
MDR Text Key207195026
Report Number0009610622-2020-00521
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 study
Reporter Occupation
Type of Report Initial
Report Date 09/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number2337-1138S
Device Catalogue Number23371138S
Device Lot NumberUNKNOWN
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 Received08/21/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 09/15/2020 Patient Sequence Number: 1
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