MAUDE Adverse Event Report: Stryker GmbH T2 - TARGETING ARM; Orthopedic manual surgical instrument

Catalog Number	18063212
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "during a t2-sga procedure, the targeting device failed to engage either of the two proximal screws in the tibia or the distal screw in the calcaneus.In both cases, the targeting device had to be removed and a freehand locking procedure attempted.While the placement of the two proximal screws in the tibia was successful using this method, the placement of the screw in the calcaneus was not.The accuracy of the targeting device was verified in advance by marking the site with the sleeve.".

• Brand Name: T2 - TARGETING ARM
• Common Device Name: Orthopedic manual surgical instrument
• Manufacturer (Section D): Stryker GmbH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): Stryker Trauma GmbH; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 25779912
• Report Number: 0008031020-2026-00827
• Device Sequence Number: 13170101
• Product Code: LXH
• UDI-Device Identifier: 04546540708496
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 09/21/2026

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: 18063212
• Device Lot Number: KME918926
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2026
• Supplement Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 07/10/2026
• Supplement Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2023
• 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