MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO NAV PIN 3MM X 100MM CASE OF 10; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	6007003100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device discarded.
Event or Problem Description
It was reported that during a procedure at the user facility a patient experienced a fracture of the femur at the diaphysis.Attempts are being made to obtain additional information about the event; no further information is currently available.
Additional Manufacturer Narrative
Additional information added for d10, h3 device evaluation: follow-up report submitted to document the device was discarded by the customer, no evaluation is possible.H3 other text : device and x-rays not available.
Event or Problem Description
It was reported that during a procedure at the user facility a patient experienced a fracture of the femur at the diaphysis.The user facility reported the patient recovered from the fracture.Multiple attempts were made to obtain additional information.The user facility was not able to provide any further information regarding the reported event.

• Brand Name: NAV PIN 3MM X 100MM CASE OF 10
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9800125
• Report Number: 0001811755-2020-00629
• Device Sequence Number: 779130
• Product Code: HAW
• UDI-Device Identifier: 57613154107396
• UDI-Public: 57613154107396
• Combination Product (Y/N): N
• PMA/510(K) Number: K022365
• 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): 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 6007003100
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/14/2020
• Supplement Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 03/06/2020
• Supplement Report FDA Received Date: 07/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1