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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 / L28MM; PLATE, FIXATION, BONE
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STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L28MM; PLATE, FIXATION, BONE Back to Search Results
Model Number 657328S
Device Problem Positioning Failure (1158)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/25/2021
Event Type  malfunction  
Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
 
Event Description
It was reported: "the locking screw did not lock and was spinning (idling) all the time.The surgeon stated that there could be problem with the screw or the locking hole because a shorter screw was choose and the angle of screw was not excessive.When the surgeon put a new screw of the same size with the same hole, it was locked without problem.The same thing happened again, and when the surgeon reinserted the screw of the same size, it was locked normally".
 
Event Description
It was reported: "the locking screw did not lock and was spinning (idling) all the time.The surgeon stated that there could be problem with the screw or the locking hole because a shorter screw was choose and the angle of screw was not excessive.When the surgeon put a new screw of the same size with the same hole, it was locked without problem.The same thing happened again, and when the surgeon reinserted the screw of the same size, it was locked normally.".
 
Manufacturer Narrative
The reported event could be not confirmed since the received screw showed no traces of damage or deformation and was found to be intact.Also, no other evidence was provided to confirm impairment in implant insertion.The received screw was found to be fine condition.No sign of any damage or deformation was noticed.The hex on the head didn¿t have any scratch marks which would suggest whether the screw has been used or not.The threads of the screw was also intact without any damage.However, based on past complaints of similar nature 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.
 
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Brand Name
LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L28MM
Type of Device
PLATE, FIXATION, BONE
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
SZ  2545
MDR Report Key11704194
MDR Text Key249748178
Report Number0008031020-2021-00176
Device Sequence Number1
Product Code HRS
UDI-Device Identifier07613327087055
UDI-Public07613327087055
Combination Product (y/n)N
PMA/PMN Number
K132502
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 06/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2023
Device Model Number657328S
Device Catalogue Number657328S
Device Lot NumberL58501
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/07/2021
Date Manufacturer Received05/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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