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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L22MM; PLATE, FIXATION, BONE
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STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L22MM; PLATE, FIXATION, BONE Back to Search Results
Model Number 657322S
Device Problems Positioning Failure (1158); Difficult to Insert (1316)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/10/2020
Event Type  malfunction  
Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
 
Event Description
As reported: "the locking screw could not be completely fastened.The doctor tried to turn it with a screwdriver many times, but i couldn't turn the screw on the way.Doctor's view: the patient's bones were stiff and the screw could not advance.The tip of the screwdriver has come off the screw head many times.It would be nice to have a screw that can be inserted even in patients with hard bones.I want the tip of the screwdriver to be shaped so that it does not come off the screw head.".
 
Manufacturer Narrative
The reported event could be confirmed.The device was returned.The inspection showed that the screw doesn't show major signs of damage.The threaded part is in a good state.However, the screw's head show some slight material deformation.A potential non-conformity report was initiated to address this event.The comprehensive root cause analysis of the potential ncr included a surface and microstructure analysis as well as nano-indent hardness measurement of variax1 and variax2 screw samples by the fraunhofer institute on behalf of stryker.Further internal investigation efforts were focusing on the anodization color difference between variax1 and variax2 screws.Significant differences between the screws which could result in the reported complaints have not been revealed in either fraunhofer or stryker investigations.Excessive in-house handling and bench testing with variax2 screws from various manufacturing batches showed that locking is achieved as intended.The desired increase in torque indicating to the customer that the screw is locking in the plate, can be confirmed.A review of the device history for the reported lot did not indicate any abnormalities.No deviation from the specifications was noted.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Considering the information given and based on the above investigations a root cause of the reported event could not be determined.If any further substantial information is provided, the investigation report will be updated.
 
Event Description
As reported: "the locking screw could not be completely fastened.The doctor tried to turn it with a screwdriver many times, but i couldn't turn the screw on the way.Doctor's view: the patient's bones were stiff and the screw could not advance.The tip of the screwdriver has come off the screw head many times.It would be nice to have a screw that can be inserted even in patients with hard bones.I want the tip of the screwdriver to be shaped so that it does not come off the screw head.".
 
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Brand Name
LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L22MM
Type of Device
PLATE, FIXATION, BONE
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
SZ  2545
MDR Report Key11121220
MDR Text Key227976844
Report Number0008031020-2021-00006
Device Sequence Number1
Product Code HRS
UDI-Device Identifier07613327086966
UDI-Public07613327086966
Combination Product (y/n)N
PMA/PMN Number
K132502
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 04/09/2021
1 Device was Involved in the Event
1 Patient was 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 Health Professional
Device Expiration Date07/31/2023
Device Model Number657322S
Device Catalogue Number657322S
Device Lot NumberY18797
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/30/2020
Date Manufacturer Received03/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age60 YR
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