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	09/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "the screws do not hit the correct position due to the target device.The screws were used manually.".
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was returned for evaluation and found to be functional in nature.The device inspection revealed the following: the received target device was found in good condition with slight wear marks in the neck region and discolored surface due to usage and cleaning cycles.No significant damage or deformation seen with respect to the alleged failure.A functional inspection was done on the returned target device using sample nail, drill and drill sleeve and it was found that the device is fully functional.The drill passed every hole in the nail comfortably without showing any signs of misdrilling / mistargeting.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 the above investigation, the root cause can be attributed user related, as in the functional inspection, device was found to be functional.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "the screws do not hit the correct position due to the target device.The screws were used manually.".

• 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 KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23299916
• Report Number: 0008031020-2025-01697
• Device Sequence Number: 4864163
• Product Code: LXH
• UDI-Device Identifier: 04546540708496
• UDI-Public: (01)04546540708496(10)K0918E9
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 01/06/2026

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: 18063212
• Device Lot Number: KME918017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/15/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2022
• 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