MAUDE Adverse Event Report: STRYKER GMBH FIXOS CANNULATED SCREWDRIVER T20, AO FITTING; SCREW, FIXATION, BONE

Catalog Number	705211
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: ¿breakage of the cannulated torx 20 screwdriver from the fixos 5.0 mm screw system.The surgical procedure was successfully completed using a second screwdriver from the instrument tray.¿.
Event or Problem Description
As reported: ¿breakage of the cannulated torx 20 screwdriver from the fixos 5.0 mm screw system.The surgical procedure was successfully completed using a second screwdriver from the instrument tray.¿.
Additional Manufacturer Narrative
The reported event could be confirmed based on the device inspection.The device inspection revealed the following: as received condition, the device is broken off at its tip.No fragments were returned for evaluation.The fracture face is diagonal which indicates high lateral stress.The view of the fracture face is typical of a brittle overload fracture (smooth surface, absence of ductile deformation).It can therefore be concluded that too much torsional and lateral forces while inserting the screw caused mechanical overload and ultimately breakage.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.Based on investigation, the root cause was attributed to a user related issue.The event was caused by excessive external forces applied during use.If more information is provided, the case will be reassessed.

• Brand Name: FIXOS CANNULATED SCREWDRIVER T20, AO FITTING
• 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: 24559416
• Report Number: 0008031020-2026-00417
• Device Sequence Number: 15819278
• Product Code: HWC
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K133451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2026

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: 705211
• Device Lot Number: 1642AB
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown