MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP INSTRUMENT BATTERY; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	6000-006-000
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that they found debris in the sterile packaging prior to a procedure.No medical intervention and no adverse consequences were reported with this event.As this event occurred during testing before a medical procedure at the user facility, there was no patient involvement and no delay to a surgical procedure.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document the device was not available for evaluation.H3 other text : no product return per the customer.
Event or Problem Description
It was reported by the customer that they found debris in the sterile packaging prior to a procedure.No medical intervention and no adverse consequences were reported with this event.As this event occurred during testing before a medical procedure at the user facility, there was no patient involvement and no delay to a surgical procedure.

• Brand Name: INSTRUMENT BATTERY
• 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-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: zach baker ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 12562669
• Report Number: 3015967359-2021-02086
• Device Sequence Number: 13813659
• Product Code: HAW
• UDI-Device Identifier: 04546540245045
• UDI-Public: 04546540245045
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2022

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: 6000-006-000
• Device Catalogue Number: 6000006000
• Device Lot Number: 2021041162
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2021
• Supplement Date Received by Manufacturer: 01/05/2022
• Initial Report FDA Received Date: 10/01/2021
• Supplement Report FDA Received Date: 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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