MAUDE Adverse Event Report: STRYKER INSTRUMENTS-FREIBURG NAVIGATION MIS JIG - B; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	6003-200-020
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	06/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Per the account, during a procedure, a set screw that fell off into the patient during the procedure.The screw was retrieved and the patient was not affected.The procedure was completed successfully without a clinically significant delay; no medical intervention or adverse consequences were reported.
Additional Manufacturer Narrative
Update: d4, d9, h3, h6.Device evaluation: follow-up report submitted to document the device evaluation.
Event or Problem Description
Per the account, during a procedure, a set screw that fell off into the patient during the procedure.The screw was retrieved and the patient was not affected.The procedure was completed successfully without a clinically significant delay; no medical intervention or adverse consequences were reported.

• Brand Name: NAVIGATION MIS JIG - B
• Common Device Name: NEUROLOGICAL 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: 19804238
• Report Number: 0008010177-2024-00066
• Device Sequence Number: 7524740
• Product Code: HAW
• UDI-Device Identifier: 04546540470355
• UDI-Public: (01)04546540470355(10)1000265212
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K150301
• 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): 11/04/2024

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: 6003-200-020
• Device Lot Number: A/07/2017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/25/2024
• Supplement Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 11/04/2024
• 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