MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L16MM; SCREW, FIXATION, BONE

Model Number 657316

Device Problem Material Fragmentation (1261)

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

Event Date 11/21/2019

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

It was reported by a customer "during the intervention, a metal part separated from the thread of the variax screw.The metal part and the screw were kept but not decontaminated.The surgeon was able to retrieve the metal part that had disengaged from the screw.Metal part and screws put in a pot.".

Manufacturer Narrative

The reported event could be confirmed.The device inspection revealed the following: the locking mechanism / thread of the returned locking screw is indeed completely damaged, most of the thread has been torqued / thorn / broken off.A close up views done by the microscope indicating that the screw head t10 drive is still intact.This gives us an indication that the screw must have been forced / inserted on a too steep angle which resulted in the separation of the first two windings of the locking thread.It can be concluded that inappropriate positioning during screw insertion (on a too steep angle) has caused these damages / abrasions.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was attributed to be user related.The failure was caused by inappropriate positioning during screw insertion (on a too steep angle).If any further information is provided, the investigation report will be updated.

Event Description

It was reported by a customer "during the intervention, a metal part separated from the thread of the variax screw.The metal part and the screw were kept but not decontaminated.The surgeon was able to retrieve the metal part that had disengaged from the screw.Metal part and screws put in a pot.".

• Brand Name: LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L16MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9490932
• MDR Text Key: 193333660
• Report Number: 0008031020-2019-02288
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07613327086874
• UDI-Public: 07613327086874
• Combination Product (y/n): N
• PMA/PMN Number: K180500
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 657316
• Device Catalogue Number: 657316
• Device Lot Number: L46157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Date Manufacturer Received: 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1