MAUDE Adverse Event Report: STRYKER GMBH VARIAX 2 BONE SCREW T10, FULL THREAD, 3.5MM / L30MM; PLATE, FIXATION, BONE

Catalog Number	657430S
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
As reported: "the non-locking screw was inserted into the fracture site following direct drilling.However, upon turning the driver, a thin wire-like object emerged from the screw insertion site, necessitating its removal.As fixation of the fracture by the screw was confirmed, the screw was not removed and was implanted in the patient's body.Subsequently, plate fixation was performed using the standard technique.The thin wire-like object was discarded at the facility.".

• Brand Name: VARIAX 2 BONE SCREW T10, FULL THREAD, 3.5MM / L30MM
• Common Device Name: PLATE, 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: 24734297
• Report Number: 0008031020-2026-00503
• Device Sequence Number: 16000250
• Product Code: HRS
• UDI-Device Identifier: 07613327074079
• UDI-Public: (01)07613327074079(17)291031(10)AK7281
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2026

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 Catalogue Number: 657430S
• Device Lot Number: AK7281
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/02/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/08/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown