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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 Problem Failure to Align (2522)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/23/2020
Event Type  malfunction  
Manufacturer Narrative
Device will not be returned. If additional information becomes available, it will be provided in a supplemental report. Device disposition is unknown.
 
Event Description
As reported: "the surgeon had inserted the drill tip k-wire and used the cannulated lag screw drill to prepare for the lag screw. The surgeon noticed an increase in resistance but managed to drill the entire track. After drilling the lag screw was attached to the lag screw screwdriver trough the proximal targeting device. The lag screw went in for a bit after which it would not get any deeper. The surgeon checked for: good attachment of the nail holding screw, right ccd angle of the targeting device and if the k-wire was still straight. The surgeon tried again with no success. After this attempt the surgeon removed the nail and lag screw and tried to insert the lag screw trough the targeting device outside the patient, but again the lag screw was running against the nail and could not progress. A new nail and lag screw were used after which the surgery progressed without any further problems. The nail and lag screw were cleaned and were brought to the mec truck which was on their property. The procedure was done again with the use of the proximal aiming device that is available in the mec truck. With the first try, the same issue was encountered. Later on the day it was shown again to someone else, and the issues were not encountered. ".
 
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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
GM D-24232
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM D-24232
Manufacturer Contact
sharon rivas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key11121326
MDR Text Key227978381
Report Number0009610622-2021-00069
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K123401
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 01/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/05/2021
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 NumberUNKNOWN
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 Received12/11/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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