MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG NAVLOCK, UNIVERSAL TRACKER ADAPTER FOR INSTRUMENTS FROM 2 TO 7MM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	6000-999-002
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Per the customer, the metal is damaged, and a piece of metal broke off it intraoperatively.Additional information has been requested from the user facility.
Event or Problem Description
It was reported that the tightening knob of a navlock universal tracker adapter was fractured intra-operatively.
Additional Manufacturer Narrative
Corrected data: d3, d5, and g1.D9 and h6 coding have been updated to reflect investigation conclusion.Additional data: b5, h4.

• Brand Name: NAVLOCK, UNIVERSAL TRACKER ADAPTER FOR INSTRUMENTS FROM 2 TO 7MM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg MI D-791 11; GM D-79111
• Manufacturer (Section G): STRYKER INSTRUMENTS-FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 18310005
• Report Number: 3015967359-2023-02583
• Device Sequence Number: 14981139
• Product Code: HAW
• UDI-Device Identifier: 04546540391902
• UDI-Public: 04546540391902
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K993239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2024

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: 6000-999-002
• Device Lot Number: X02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2023
• Supplement Date Received by Manufacturer: 03/06/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2007
• 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