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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 / L60MM PLATE, FIXATION, BONE

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STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L60MM PLATE, FIXATION, BONE Back to Search Results
Model Number 657360
Device Problem Device Inoperable (1663)
Patient Problem No Information (3190)
Event Date 04/24/2018
Event Type  malfunction  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
Primary procedure, right proximal ulna. It was reported that in inserting a vari-ax 2 core locking screw into the plate, the screw would not lock. The surgeon removed the screw and tried another. The second screw would not lock. A different plate was implanted and vari-ax (not vari-ax 2) locking screws were used. The screws locked into the plate. At the back table, the heads of the first 2 screws appeared to be compromised. A third vari-ax 2 locking screw was inspected and found to be free of defect. When inserting the screw into the plate, it would not lock. The screw was removed and the head appeared to be compromised. A vari-ax screw was then inserted in the same hole as the first screws and it locked with no issue. Rep reported a surgical delay of approximately 30-40 minutes. Rep reported via phone that the third screw was discarded.
 
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Brand NameLOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L60MM
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
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7531490
MDR Text Key108995835
Report Number0008031020-2018-00371
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
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 08/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number657360
Device Catalogue Number657360
Device Lot NumberL38322
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/25/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/19/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/07/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/22/2018 Patient Sequence Number: 1
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