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

Catalog Number	657320S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "primary surgery was performed on (b)(6) 2025.Two months after surgery, an x-ray revealed that the 2 locking screws inserted on the outside plate had backed out of the plate and the lock had come loose.The screws inserted into the first and third holes from the outer side of the plate backed out.It is unclear which of the screws actually backed out.The patient is originally a farmer and, according to reports, resumed work three weeks after surgery without following the doctor's instructions.Revision surgery is scheduled on (b)(6) 2025.".
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "primary surgery was performed on (b)(6) 2025.Two months after surgery, an x-ray revealed that the 2 locking screws inserted on the outside plate had backed out of the plate and the lock had come loose.The screws inserted into the first and third holes from the outer side of the plate backed out.It is unclear which of the screws actually backed out.The patient is originally a farmer and, according to reports, resumed work three weeks after surgery without following the doctor's instructions.Revision surgery is scheduled on (b)(6) 2025".
Additional Manufacturer Narrative
Please note correction to g1 (reporting contact).The reported event could not be confirmed since based on the product inspection, the returned device was assessed as one of the screws that did not back out from the plate.The device inspection revealed the following: this screw is overall in good condition.There are slight marks of usage on the head and the threads are slightly blunt due to being inserted, but nothing suggesting the screw was incorrectly implanted or has backed out.All 4 locking screws were inserted into the locking holes of the plates.Each screw was tested for each hole.They could be locked as intended.Therefore the event cannot be confirmed for this locking screw l20 (lot aj1191).The screw did not contribute to the event as it did not back out, also evidenced by the provided x-rays.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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22378064
• Report Number: 0008031020-2025-01037
• Device Sequence Number: 8091743
• Product Code: HWC
• UDI-Device Identifier: 07613327086942
• UDI-Public: (01)07613327086942(17)290630(10)AJ1191
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 657320S
• Device Lot Number: AJ1191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2025
• Supplement Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2024
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian