MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PRECISION POINTER ELECTROMAGNETIC; ENT NAVIGATION ACCESSORIES

Model Number	8000-050-001
Medical Device Problem Codes	No Device Output (1435); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure at the user facility the physician used the precision pointer, but bent it above the tip.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Additional information added for d9, h3, h6.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 physician used the precision pointer, but bent it above the tip. the procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.

• Brand Name: PRECISION POINTER ELECTROMAGNETIC
• Common Device Name: ENT NAVIGATION ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 10554166
• Report Number: 0001811755-2020-02416
• Device Sequence Number: 3145642
• Product Code: OLO
• UDI-Device Identifier: 07613327413205
• UDI-Public: 07613327413205
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2021

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: 8000-050-001
• Device Catalogue Number: 8000-050-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Initial Date Received by Manufacturer: 09/09/2020
• Supplement Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 03/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1