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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, RIGHT GAMMA3® Ø11X320MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, RIGHT GAMMA3® Ø11X320MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 32250320S
Device Problems Defective Device (2588); Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/15/2019
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. If additional information becomes available it will be provided on a supplemental report. Device evaluated by mfr: device disposition is unknown.
 
Event Description
The following report was received from (b)(6): during the removal of a gamma nail long, used to reduce a multifragmented right femur fracture, distally and proximally blocked, the surgeon has noticed visible signs of rubbing of the cephalic screw on the nail in an abnormal location: out of the channel that normally houses the cephalic screw. The system is normally used percutaneously, so without a direct view of the operator but only via rx. The system is collimated by cannulas that allow this procedure. So customer reports that the incident is inexplicable except with an alleged defect in the instruments. Adverse event: asymmetry, lack of bone calcification.
 
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Brand NameLONG NAIL KIT R2.0, TI, RIGHT GAMMA3® Ø11X320MM X 125°
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 Key8596807
MDR Text Key144670298
Report Number0009610622-2019-00241
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K034002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 08/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number32250320S
Device Lot NumberK0DFBE0
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/22/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/27/2017
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: 05/09/2019 Patient Sequence Number: 1
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