MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP POINTER, RIGHT POSTERIOR-FOSSA; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	6001-022-000
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Per the customer, the device was bent which can lead to inaccuracy.The procedure was completed successfully without a surgical delay; no medical intervention or adverse consequences were reported.
Event or Problem Description
Per the customer, the device was bent which can lead to inaccuracy.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.

• Brand Name: POINTER, RIGHT POSTERIOR-FOSSA
• 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: 16156868
• Report Number: 3015967359-2023-00059
• Device Sequence Number: 7469921
• Product Code: HAW
• UDI-Device Identifier: 04546540245809
• UDI-Public: 04546540245809
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 05/23/2023

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: 6001-022-000
• Device Catalogue Number: 6001-022-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2022
• Supplement Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 05/23/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown