MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO POINTER, RIGHT POSTERIOR-FOSSA; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	6001-022-000
Medical Device Problem Codes	Imprecision (1307); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure at the user facility the device tip was bent after validation.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
Event or Problem Description
It was reported that during a procedure at the user facility the device tip was bent after validation.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.

• Brand Name: POINTER, RIGHT POSTERIOR-FOSSA
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 10600999
• Report Number: 0001811755-2020-02522
• Device Sequence Number: 1192348
• 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): 03/25/2021

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: No Information
• Device Model Number: 6001-022-000
• Device Catalogue Number: 6001-022-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 09/29/2020
• Supplement Report FDA Received Date: 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1