MAUDE Adverse Event Report: STRYKER GMBH THREADED DRILL TOWER FOR T8 SCREW HOLES VARIAX 2; PLATE, FIXATION, BONE

Catalog Number	706620
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
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: "when attempting to install two drill towers on the plate to the bone, the tip of the drill tower attached to the radial side was chipped off.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned broken.The device inspection revealed the following: the threading of the drill tower shows a breakage at the edge.The fracture surface exhibits a combination of granular and smooth features characteristic of a brittle failure, without signs of plastic deformation.Therefore, the damage most likely occurred due to excessive mechanical load during use, such as cross-threading, misalignment, or excessive torque.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 mechanical load during installation of the device.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "when attempting to install two drill towers on the plate to the bone, the tip of the drill tower attached to the radial side was chipped off.".

• Brand Name: THREADED DRILL TOWER FOR T8 SCREW HOLES VARIAX 2
• 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: 22962740
• Report Number: 0008031020-2025-01456
• Device Sequence Number: 15862043
• Product Code: HRS
• UDI-Device Identifier: 07613327615807
• UDI-Public: 07613327615807
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K233919
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2025

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: 706620
• Device Lot Number: 40397901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/07/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2025
• 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 Age: 62 YR
• Patient Sex: Female