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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGET DEVICE GAMMA3® ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL TARGET DEVICE GAMMA3® ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 1320-0111
Device Problems Entrapment of Device (1212); Difficult to Remove (1528)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Event Date 10/11/2019
Event Type  malfunction  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
At the time the surgeon was going to implant the gamma nail, the arch became trapped in the nail entry thread. At the time the surgeon tried to remove the arch, it had to be removed with the implant included. Aditionally, it was necessary to remove all screws that were place into the patient. To finished the surgery it was necessary to open a new implant and the patient had to receive double anesthesia for the operative time.
 
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Brand NameTARGET DEVICE GAMMA3®
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
D-24232
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
postfach
schoenkirchen/kiel D-242 32
D-24232
Manufacturer Contact
kevin smith
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key9319380
MDR Text Key191808211
Report Number0009610622-2019-00921
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K123401
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation Physician Assistant
Type of Report Initial,Followup,Followup
Report Date 03/26/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1320-0111
Device Catalogue Number13200111
Device Lot NumberKME912596
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/26/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/18/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/26/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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