• 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 LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L12MM PLATE, 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 LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L12MM PLATE, FIXATION, BONE Back to Search Results
Model Number 657312S
Device Problems Material Fragmentation (1261); Difficult to Insert (1316)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/15/2020
Event Type  malfunction  
Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided. Additional information reported that: after drilling and before inserting the screw, drilling into the next screw hole was made and then inserting the screw. This caused the plate to shift and the drill hole to be shifted from the initial position, which seemed to have caused locking failure. Based on investigation, the root cause was attributed to a user related issue. The failure was caused by misalignment of the implant before screw insertion. More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event. If the device is returned or if any additional information is provided, the investigation will be reassessed. Device discarded.
 
Event Description
It was reported, when the locking screw was inserted during the variax fibula operation, locking failure occurred. It seemed that the angle of the screw was too inclined, but the drill guide was in the normal range. When the screw was turning to lock, a piece of metal came out of between the plate and the screw. A new locking screw of the same size was opened and reinserted, and it was locked. The operation is completed successfully. Additional information reported that: after drilling and before inserting the screw, drilling into the next screw hole was made and then inserting the screw. This caused the plate to shift and the drill hole to be shifted from the initial position, which seemed to have caused locking failure. Customer / sales rep confirmed that no further information is available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L12MM
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH 2545
Manufacturer (Section G)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH 2545
Manufacturer Contact
sharon rivas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key9702276
MDR Text Key193365601
Report Number0008031020-2020-00346
Device Sequence Number1
Product Code HRS
UDI-Device Identifier07613327086829
UDI-Public07613327086829
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number657312S
Device Catalogue Number657312S
Device Lot NumberD50232
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/27/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/11/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-