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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 Difficult or Delayed Positioning (1157); Failure to Align (2522)
Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Event Date 10/19/2019
Event Type  malfunction  
Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
 
Event Description
The customer reported to our sales rep that: "i have a gamma nail handpiece to send back for quality control because we had a problem this weekend. [surgeon], during his intervention, noticed that the viewfinder was a little "screwed up" and as a result the drill broke in the patient. ".
 
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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
schoenkirchen/kiel D-242 32
D-24232
Manufacturer Contact
kevin smith
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key9333096
MDR Text Key191824349
Report Number0009610622-2019-00927
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K123401
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/26/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/16/2019
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 NumberKME910549
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 Received02/26/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/20/2018
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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