MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX 2 T10, FULL THREAD, 3.5MM / L16MM; SCREW, FIXATION, BONE

Model Number 657316S

Device Problem Positioning Failure (1158)

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

Event Date 01/17/2023

Event Type  malfunction  

Event Description

As reported: "the 3.5 mm locking screw did not lock with the variax fibraplate.Replaced new screw.".

Manufacturer Narrative

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

Event Description

As reported: "the 3.5 mm locking screw did not lock with the variax fibraplate.Replaced new screw.".

Manufacturer Narrative

The reported event could not 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.Usage marks and discoloration were observed on the head and on the thread of the screw, most probably due to the failed locking and friction with the plate and the bone.No major deformation or wear impairing the screw's functionality could be observed.The returned screw was tested with a fully functional variax distal medial humerus plate, also intended for t10 locking screws.The screw could be locked as intended, no issue was observed.Therefore, the functionality of the device was still fully given and the reported event could not be confirmed.Based on investigation, the root cause was attributed to an user related issue.The reported event was probably caused by inadequate insertion and locking of the screw.However, the root cause of the failure could not be identified.As a reminder, the operative technique clearly state: ¿ it is important that any nonlocking screw is inserted before any locking screw.Locking screws should not be used in the oblong holes of the plate.¿ it must be noted that 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¿ according to capa, for corrective actions, the design of the variax 2 locking screws t10, 3.5mm ref 657308(s)-70(s) and t10, 2.7mm ref 657008(s)-70(s) shall be changed to increase the torque to failure of the locking 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 VARIAX 2 T10, FULL THREAD, 3.5MM / L16MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16353085
• MDR Text Key: 309380706
• Report Number: 0008031020-2023-00082
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07613327086881
• UDI-Public: 07613327086881
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K132502
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 657316S
• Device Catalogue Number: 657316S
• Device Lot Number: K61896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2022
• 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