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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX 2 T10, FULL THREAD, 3.5MM / L16MM; PLATE, FIXATION, BONE

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STRYKER GMBH LOCKING SCREW VARIAX 2 T10, FULL THREAD, 3.5MM / L16MM; PLATE, FIXATION, BONE Back to Search Results
Model Number 657316S
Device Problems Positioning Failure (1158); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/09/2022
Event Type  malfunction  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
As reported: "the screw did not lock to the plate.The lip of the screw damaged.".
 
Manufacturer Narrative
The reported event could be confirmed.The returned locking screw was inspected under a microscope.The thread below the screw head which is intended to lock the screw in the plate, shows plastic deformation which could explain the loss of the angular locking ability.Some portions of the crest of the thread flank have separated / have sheared off under significant force.The damage pattern suggests high force application during locking attempts.Related to our post market surveillance activities a potential non-conformity report (nc) was initiated to address similar events related to the variaax2 locking feature.The deep investigation of the nc revealed that the application of over torque during insertion was the root cause of the event.This leads to the damage of the smart lock technology below the head.As a reminder, the operative technique (vax-st-49_rev.5, 05 - 2021) clearly states that the proper use of the screw should prevent this deformation from happening: ¿caution ¿ with the use of variable speed power systems, the surgeon should initially reduce the power to the lowest setting.¿ final tightening of the screw should be performed by hand to avoid damaging the screw-plate interface¿ however, although no product related issue could be detected a preventive action (capa) was nonetheless opened to make the design more robust against a potential over tightening by the user.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.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by over tightening of the locking screw in the final position, which did lead to a deformation of the locking thread.If any further substantial information is provided, the investigation report will be updated.
 
Event Description
As reported: "the screw did not lock to the plate.The lip of the screw damaged.".
 
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Brand Name
LOCKING SCREW VARIAX 2 T10, FULL THREAD, 3.5MM / L16MM
Type of Device
PLATE, FIXATION, BONE
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
SZ  2545
Manufacturer (Section G)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
SZ   2545
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key14012516
MDR Text Key288874743
Report Number0008031020-2022-00142
Device Sequence Number1
Product Code HRS
UDI-Device Identifier07613327086881
UDI-Public07613327086881
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K132502
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number657316S
Device Catalogue Number657316S
Device Lot NumberH61377
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/23/2022
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/10/2022
Initial Date FDA Received04/05/2022
Supplement Dates Manufacturer Received06/07/2022
Supplement Dates FDA Received06/28/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/21/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age46 YR
Patient SexMale
Patient Weight70 KG
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