MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG ARM CONNECTOR COMPONENT; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	6000-806-000
Medical Device Problem Codes	Imprecision (1307); Material Deformation (2976); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a case, an arm connector component did not connect properly to the mayfield adapter and that a screw on the connector component was found to be deformed.
Additional Manufacturer Narrative
H6 coding has been updated to reflect investigation conclusion.Additional data: d4, h4.
Event or Problem Description
It was reported that during a case, an arm connector component did not connect properly to the mayfield adapter and that a screw on the connector component was found to be deformed.

• Brand Name: ARM CONNECTOR COMPONENT
• 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 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: 20152026
• Report Number: 0008010177-2024-00096
• Device Sequence Number: 8301524
• Product Code: HAW
• UDI-Device Identifier: 07613327467253
• UDI-Public: (01)07613327467253(11)210907(21)6000090391
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K212194
• 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): 11/22/2024

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: 6000-806-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2024
• Supplement Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/07/2021
• 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