MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP UNIVERSAL TRACKER ELECTROMAGNETIC; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	8000-060-006
Medical Device Problem Codes	Incorrect Measurement (1383); Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Per the customer, it was reported that "the universal tracker became loose from the holding pin to the instrument clamp.Resulted in inaccuracy with navigation system".The procedure was completed successfully without a surgical delay; no medical intervention or adverse consequences were reported.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document the device evaluation.
Event or Problem Description
Per the customer, it was reported that "the universal tracker became loose from the holding pin to the instrument clamp.Resulted in inaccuracy with navigation system".The procedure was completed successfully without a surgical delay; no medical intervention or adverse consequences were reported.

• Brand Name: UNIVERSAL TRACKER ELECTROMAGNETIC
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 16639741
• Report Number: 3015967359-2023-00643
• Device Sequence Number: 5352875
• Product Code: HAW
• UDI-Device Identifier: 07613327413212
• UDI-Public: 07613327413212
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K221098
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2023

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 Model Number: 8000-060-006
• Device Catalogue Number: 8000-060-006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2023
• Supplement Date Received by Manufacturer: 06/12/2023
• Initial Report FDA Received Date: 03/29/2023
• Supplement Report FDA Received Date: 06/12/2023
• 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 Age: 21 YR
• Patient Sex: Male