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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø10X170MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø10X170MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 31250170S
Device Problems Collapse (1099); Material Protrusion/Extrusion (2979)
Patient Problem Necrosis (1971)
Event Date 05/07/2019
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. If additional information becomes available, it will be provided in a supplemental report. Device evaluated by mfr: hospital policy.
 
Event Description
Rep reported that the surgeon revised a gamma nail to a rest mod tha with mdm. The patient received the gamma nail about 2 years ago for a femoral fracture, then developed avascular necrosis. Subsequent collapse of the femoral head has resulted in the lag screw protruding into the joint space requiring revision.
 
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Brand NameTROCHANTERIC NAIL KIT, TI GAMMA3® Ø10X170MM 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
kevin smith
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8631624
MDR Text Key145767847
Report Number0009610622-2019-00280
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K034002
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 07/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2021
Device Catalogue Number31250170S
Device Lot NumberK0D8E59
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 Received06/27/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/14/2016
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: 05/22/2019 Patient Sequence Number: 1
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