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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL SUPRACONDYLAR NAIL T2 SCN Ø13X400MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL SUPRACONDYLAR NAIL T2 SCN Ø13X400MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 18261340S
Device Problem Fracture (1260)
Patient Problem Fall (1848)
Event Date 01/08/2019
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. If additional information becomes available it will be provided on a supplemental report.
 
Event Description
This pi is for the revision of the t2 nail. While reporting a revision of patient's left knee, rep reported that after patient had knee implanted, patient fell and sustained a femoral fracture. A t2 nail was implanted to address the fracture and was later removed at an unknown date for an unknown reason.
 
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Brand NameSUPRACONDYLAR NAIL T2 SCN Ø13X400MM
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8304870
MDR Text Key134998259
Report Number0009610622-2019-00064
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K023267
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 02/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2020
Device Catalogue Number18261340S
Device Lot NumberK0C1705
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 Received01/08/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/02/2015
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: 02/05/2019 Patient Sequence Number: 1
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