MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX 2 T10, FULL THREAD, 3.5MM / L20MM; SCREW, FIXATION, BONE

Model Number	657320S
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "open osteosynthesis was performed for right clavicle.When the 3.5mm*20mm locking screw was inserted into the screw hole of the plate, the locking failure occurred.There was no particular problem with the procedure up to the insertion of the screw.".
Event or Problem Description
As reported: "open osteosynthesis was performed for right clavicle.When the 3.5mm*20mm locking screw was inserted into the screw hole of the plate, the locking failure occurred.There was no particular problem with the procedure up to the insertion of the screw.".
Additional Manufacturer Narrative
Please note the corrections to h6 clinical signs and h6 health impact codes.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.The locking screw was tested with a fully functional clavicle variax plate sample.The locking could be performed as intended, without any issue.Therefore, the reported event was not confirmed and it has been proven that the locking screw is fully functional.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¿ however, although no product related issue could be detected a preventive action was nonetheless opened to make the design more robust against a potential over tightening by the user.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 / L20MM
• Common Device Name: 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: 16353554
• Report Number: 0008031020-2023-00085
• Device Sequence Number: 20590550
• Product Code: HWC
• UDI-Device Identifier: 07613327086942
• UDI-Public: 07613327086942
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 657320S
• Device Catalogue Number: 657320S
• Device Lot Number: H59450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2023
• Supplement Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 02/10/2023
• Supplement Report FDA Received Date: 03/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Sex: Male