MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW,T8 FULL THREAD, 2.7MM/L24MM; SCREW, FIXATION, BONE

Model Number 656324

Device Problem Positioning Failure (1158)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/21/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported: "variax2 angle stable screw no longer held when replacing.".

Event Description

As reported: "variax2 angle stable screw no longer held when replacing.".

Manufacturer Narrative

The reported event could be confirmed.The device inspection revealed the following: the identification of the returned locking screw was confirmed based on the catalog # and the lot # marked.The threads below the head, intended for locking, are damaged.The wear observed is most probably due to excessive torque applied when inserting the screw and due to possible screw angulation outside of the range of -15° to 15°.The screw was tested with a fully functional variax distal radius plate.The screw kept spinning on the hole and the locking could not be performed as intended.Therefore, the functionality of the device could not be given and the reported event was confirmed.Based on investigation, the root cause was attributed to an user related issue.The screw could not be properly locked in the plate due to the damages observed on the screw's threads, most probably resulting from mishandling.Related to post market surveillance activities, a potential non-conformity report was initiated to address similar events related to the variaax2 locking feature.The deep investigation of the nc revealed that the application of over torque during insertion was the root cause of the event.This leads to the damage of the smart lock technology below the head.As a reminder, the operative technique clearly states that the proper use of the screw should prevent this deformation from happening: ¿caution: with the use of variable speed power systems, the surgeon should initially reduce the power to the lowest setting.Final tightening of the screw should be performed by hand to avoid damaging the screw-plate interface¿ 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.If more information is provided, the case will be reassessed.

• Brand Name: LOCKING SCREW,T8 FULL THREAD, 2.7MM/L24MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16371085
• MDR Text Key: 309494524
• Report Number: 0008031020-2023-00087
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07613327068726
• UDI-Public: 07613327068726
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K180500
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 656324
• Device Catalogue Number: 656324
• Device Lot Number: 1000427766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2020
• 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 Age: 64 YR
• Patient Sex: Male