MAUDE Adverse Event Report: Stryker Leibinger Freiburg Precision pointer Electromagnetic; Neurological Stereotaxic Instrument

Catalog Number	8000-050-001
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During the first use of the pointer, the surgeon placed the pointer inside the patient and identified the frontal sinus.As the pointer was being removed, it came apart at pointer tube.The device was then removed from the field and the procedure was completed successfully with another pointer, without a clinically significant delay; no adverse consequences or medical intervention were reported.

• Brand Name: Precision pointer Electromagnetic
• Common Device Name: Neurological Stereotaxic Instrument
• Manufacturer (Section D): Stryker Leibinger Freiburg; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer (Section G): Stryker Leibinger Freiburg; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: elena weber ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; +49()7614888208
• MDR Report Key: 50221908
• Report Number: 0008010177-2026-00138
• Device Sequence Number: 5496799
• Product Code: PGW
• UDI-Device Identifier: 07613327413205
• UDI-Public: (01)07613327413205
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K161491
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/12/2026

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
• Device Catalogue Number: 8000-050-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/23/2026
• Initial Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown