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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 11X420MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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STRYKER TRAUMA KIEL FEMORAL NAIL PF, RIGHT T2 ALPHA FEMUR ANTEGRADE 11X420MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 2337-1142S
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Nonunion/Delayed-union Bone Fracture (2369)
Date of Event 12/16/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device is not available; device remains implanted in patient.
 
Event or Problem Description
As reported: "x-rays of the right femur shows stable alignment and fixation with no signs of broken screws, however, fracture site really is not showing much in terms of consolidation for somebody who is so young at 4 months out.".
 
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Brand Name
FEMORAL NAIL PF, RIGHT T2 ALPHA FEMUR ANTEGRADE 11X420MM
Common Device Name
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM  D-24232
MDR Report Key11346687
Report Number0009610622-2021-00287
Device Sequence Number2590415
Product Code HSB
UDI-Device Identifier07613327289190
UDI-Public07613327289190
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
K191271
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Lay User/Patient
Device Model Number2337-1142S
Device Catalogue Number23371142S
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/26/2021
Initial Report FDA Received Date02/18/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age25 YR
Patient Weight80
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