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

Catalog Number	657416S
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
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 d1 (product long description), d4 (catalog # and gtin), d9 (product available to stryker), and g1 (reporting contact).Following product return, it has been determined that this device is a bone screw.Therefore, this device is no longer reportable and will now be revised to concomitant as the event pertains to locking screws.Furthermore, mfr report # 0008031020-2025-01041 is cancelled too.
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".

• Brand Name: BONE SCREW VARIAX 2 T10, FULL THREAD, 3.5MM / L16MM
• 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: 22378357
• Report Number: 0008031020-2025-01041
• Device Sequence Number: 19987934
• Product Code: HWC
• UDI-Device Identifier: 07613327073812
• UDI-Public: 07613327073812
• 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: 657416S
• Device Lot Number: AK1037
• Was Device Available for Evaluation?: No
• 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): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian