Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN VARIAX SCREW; SCREW, FIXATION, BONE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER GMBH UNKNOWN VARIAX SCREW; SCREW, FIXATION, BONE Back to Search Results
Catalog Number UNK_SEL
Device Problems Migration (4003); Inaccurate Information (4051)
Patient Problems Failure of Implant (1924); Impaired Healing (2378); Insufficient Information (4580)
Event Date 05/06/2022
Event Type  Injury  
Event Description
It was reported that a patient had surgery and has not been progressing as well as they should with healing.After an x-ray it is shown that the screws have come away from the implanted plate and the plate has come off of the bone.Patient is potentially awaiting revision but unconfirmed.It is noted that the surgeon used an axos plate with variax screws for the surgery.
 
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.Device remains implanted in patient.
 
Manufacturer Narrative
Please note corrections to h6 device code and h6 clinical signs code, h6 health impact code.The reported event could not be confirmed, since the device was not returned, and no other evidence was provided for evaluation.A device inspection was not possible since the affected device was not returned, and no other evidence was provided for investigation.The batch record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.Considering the event description, since the surgeon fixed the axsos plate with variax screws the most probable cause of the issue seems to be the incompatibility between the devices used.The axsos plates are not supposed to be used with variax screws.The surgeon is alleging a product mix-up due to mislabeling but more information such as patient¿s medical records, the device and the original packaging must be available in order to determine the exact root cause of the issue.If the device is returned or if any additional information is provided, the investigation will be reassessed.
 
Event Description
It was reported that a patient had surgery and has not been progressing as well as they should with healing.After an x-ray it is shown that the screws have come away from the implanted plate and the plate has come off of the bone.Patient is potentially awaiting revision but unconfirmed.It is noted that the surgeon used an axos plate with variax screws for the surgery.Additional information 31 aug 2022: the event occurred during a variax case to fix the ankle of the patient.The surgeon wanted to use a variax plate but unintentionally took an axsos 1/3 tubular plate that was present in the operating room and used variax 3.5 mm screws.The surgeon is alleging against the labelling and marking of the plates that led to this unintentional off-label use.They could not distinguished in the operative room if it was an axsos or variax plate.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UNKNOWN VARIAX SCREW
Type of Device
SCREW, 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 Key14691154
MDR Text Key294022597
Report Number0008031020-2022-00282
Device Sequence Number1
Product Code HWC
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue NumberUNK_SEL
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/03/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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 Outcome(s) Other;
-
-