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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 12X440MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL FEMORAL NAIL GT, LEFT T2 ALPHA FEMUR ANTEGRADE 12X440MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 2331-1244S
Device Problem Fracture (1260)
Patient Problems Failure of Implant (1924); Discomfort (2330)
Event Date 06/25/2021
Event Type  Injury  
Manufacturer Narrative
Upon completion of the investigation any additional information will be communicated in a supplemental report.
 
Event Description
It was reported the patient had previous surgery (b)(6) 2021 for a left proximal femur fracture that was treated with a t2 alpha recon nail. After 3 months the nailed failed at the inferior recon screw hole. Patient told the surgeon that she had only been doing pt when she felt something uncomfortable in her left hip. X-ray confirmed that the implant had failed. On (b)(6) 2021 the broken t2 alpha recon nail was removed and revised with a synthes tfna.
 
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Brand NameFEMORAL NAIL GT, LEFT T2 ALPHA FEMUR ANTEGRADE 12X440MM
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
kristen canter
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key12169625
MDR Text Key265168161
Report Number0009610622-2021-00596
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 health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2331-1244S
Device Catalogue Number23311244S
Device Lot NumberK093D71
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/06/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/26/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/12/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 07/14/2021 Patient Sequence Number: 1
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