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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FEMORAL NAIL, LEFT T2 GTN 9X380 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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STRYKER TRAUMA KIEL FEMORAL NAIL, LEFT T2 GTN 9X380 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 1850-0938S
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 01/29/2021
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 in the possession of the patient.
 
Event or Problem Description
As reported: "t2gtn intramedullary nail breakage in a patient inserted 2 years ago.Broken at the proximal oblique side stop.Remove and insert t2agt." "re-fracture".
 
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Brand Name
FEMORAL NAIL, LEFT T2 GTN 9X380 MM
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 Key11382410
Report Number0009610622-2021-00309
Device Sequence Number4125348
Product Code HSB
UDI-Device Identifier04546540646460
UDI-Public04546540646460
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K101438
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/25/2021
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? Yes
Operator of Device Health Professional
Device Model Number1850-0938S
Device Catalogue Number18500938S
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/29/2021
Initial Report FDA Received Date02/25/2021
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 Required Intervention;
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