MAUDE Adverse Event Report: STRYKER INSTRUMENTS-FREIBURG PATIENT TRACKER ELECTROMAGNETIC; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT

Catalog Number	8000040001
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events 5 events were reported for this quarter.Product return status 5 devices had investigation types that have not yet been determined.Evaluation findings (results/components) 5 devices: results pending completion of investigation / part/component/sub-assembly term not applicable.Product disposition 5 devices: product disposition is not yet determined.Additional information 5 devices were not labeled for single-use.5 devices were not reprocessed or reused.
Event or Problem Description
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Events occurred between october 1 ¿ december 31 2025.This report summarizes 5 events for the failure: incorrect measurement.4 events had no health consequences or impact.1 event had problem identified before clinical use/exposure; there was no patient involvement.
Event or Problem Description
No change.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale: corrected data: b5, h6, h11.5 previously reported events were included in this follow-up record.Product return status: 2 devices were received.2 devices were not available for evaluation.1 device investigation type has not yet been determined.Evaluation findings (results/components): 1 device: electrical/electronic component problem identified / sensor; 2 devices: no findings available / part/component/sub-assembly term not applicable; 1 device: results pending completion of investigation / part/component/sub-assembly term not applicable; 1 device: no device problem found / part/component/sub-assembly term not applicable.Product disposition: 2 devices: scrapped by stryker, 2 devices: product not received, 1 device: product disposition is not yet determined.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale: corrected data: b5, h6, h11.5 previously reported events were included in this follow-up record.Product return status: 2 devices were received.3 devices were not available for evaluation.Evaluation findings (results/components): 1 device: electrical/electronic component problem identified / sensor; 3 devices: no findings available / part/component/sub-assembly term not applicable; 1 device: no device problem found / part/component/sub-assembly term not applicable.Product disposition: 2 devices: scrapped by stryker; 3 devices: product not received.
Event or Problem Description
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Events occurred between (b)(6) 2025.This report summarizes 5 events for the failure: incorrect measurement.5 events had no health consequences or impact.

• Brand Name: PATIENT TRACKER ELECTROMAGNETIC
• Common Device Name: EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer (Section G): STRYKER INSTRUMENTS-FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: kelsey barla ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 24163396
• Report Number: 0008010177-2026-99001
• Device Sequence Number: 9368943
• Product Code: PGW
• UDI-Device Identifier: 07613327413229
• UDI-Public: 07613327413229
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 5
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/28/2026

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: 8000040001
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/31/2025
• Supplement Date Received by Manufacturer: 12/31/2025; 12/31/2025
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 04/24/2026; 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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