MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW,T8 FULL THREAD, 2.7MM/L18MM; SCREW, FIXATION, BONE

Model Number 656318S

Device Problem Positioning Failure (1158)

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

Event Date 01/05/2023

Event Type  malfunction  

Manufacturer Narrative

Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.Device disposition unknown.

Event Description

As reported: "when locking the screw to the plate, once it was locked, it spun out when a little torque was applied.".

Event Description

As reported: "when locking the screw to the plate, once it was locked, it spun out when a little torque was applied.".

Manufacturer Narrative

The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history for the reported lot did not indicate any abnormalities.No deviation from the specifications was noted.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.No product related issue could be detected and without evaluation of the affected screw the root cause of this event cannot be defined.However, related the reported failure mode regarding the locking of the variax2 screw it can be mentioned that as part of our post market surveillance activities a potential non-conformity report (nc) 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¿ if any further substantial information or the material is provided, the investigation report will be updated.

• Brand Name: LOCKING SCREW,T8 FULL THREAD, 2.7MM/L18MM
• 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: 16269489
• MDR Text Key: 308482572
• Report Number: 0008031020-2023-00039
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07613327070705
• UDI-Public: 07613327070705
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K180500
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 656318S
• Device Catalogue Number: 656318S
• Device Lot Number: 1000492242
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2022
• 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
• Patient Sex: Male