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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 Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/16/2020
Event Type  malfunction  
Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
 
Event Description
As reported: "dts system didn¿t match the distal holes of gamma3 long nail.After some cross-check has been discovered that the defected part was the targeting arm.To complete the surgery, surgeon went by hand as in the old technique.The problem occurred with a left nail.So agent did the tests with the left mask and the dynamic mask.".
 
Event Description
As reported: "dts system didn¿t match the distal holes of gamma3 long nail.After some cross-check has been discovered that the defected part was the targeting arm.To complete the surgery, surgeon went by hand as in the old technique.The problem occurred with a left nail.So agent did the tests with the left mask and the dynamic mask.".
 
Manufacturer Narrative
The reported event could be confirmed, as the returned device matches the reported failure mode.The device inspection revealed the following: the received target device gamma3® shows traces of a frequent and intense use.The printings on the target device were turned from white to fawn; an indication for a high level of sterilization cycles.Furthermore, the printing ¿do not hit¿ is evidently scratched.Several signs of impacts are visible and a destroyed thread for assembling of the strike plate resp.Extraction rod could be verified.Functional inspection: a pre-surgical function test was performed on the target device returned.Sample nail and sample instruments were used.At the distal drill holes a slight contact could be verified.The alleged mis-targeting could be reproduced.Dimensional inspection: due to product condition [signs of impacts, hitting marks] of the returned device, a dimensional inspection was performed at undamaged areas only, which verified the item to be as defined per specification.However, during manufacturing, functionality test and dimensional inspection were done according to specifications.During the inspection, all devices met the specifications.However, due to the age of the device and the several evident signs of damage [signs of impacts, hammer marks] the root cause is rather related to a rough handling in combination with wear and tear of the device, otherwise the problem would have been noticed from the beginning on which has not been the case.Nevertheless, as reported in the current case the surgery was finished in freehand technique which is always an option.Finally, each device suffers from an intense and frequent use and due to damage found it should not be used any longer.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.
 
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Brand Name
TARGET DEVICE GAMMA3
Type of Device
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM  D-24232
MDR Report Key10286353
MDR Text Key199749188
Report Number0009610622-2020-00327
Device Sequence Number1
Product Code HSB
UDI-Device Identifier04546540716774
UDI-Public04546540716774
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
Type of Report Initial,Followup
Report Date 11/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1320-0111
Device Catalogue Number13200111
Device Lot NumberKME906324
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/23/2020
Date Manufacturer Received10/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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