MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN VARI-AX 2 CORE LOCKING 3.5 SCREW; IMPLANT

Catalog Number UNK_SEL

Device Problem Mechanics Altered (2984)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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.Screw was discarded.

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.

• Brand Name: UNKNOWN VARI-AX 2 CORE LOCKING 3.5 SCREW
• Type of Device: IMPLANT
• 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 Key: 7531473
• MDR Text Key: 108996616
• Report Number: 0008031020-2018-00369
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2018
• 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 Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR