MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP NAV PIN 3MM X 150MM CASE OF 10; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	6007003150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the customer, when using the navigation device two pins were used to stand the tracker on the femur, one of which penetrated the cortical bone, causing a supracondylar fracture.The customer states that after the total knee arthroplasty procedure was completed a supracondylar fracture occurred and the patient underwent revision surgery and plate fixation at a later date.Per further clarification from the surgeon, "the patient's bone quality is not strong," in the area where the pins were placed.Attempts are being made to obtain additional information from the user facility.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document the device was not available.For evaluation.H3 other text : no product return.
Event or Problem Description
Per the customer, when using the navigation device two pins were used to stand the tracker on the femur, one of which penetrated the cortical bone, causing a supracondylar fracture.The customer states that after the total knee arthroplasty procedure was completed a supracondylar fracture occurred and the patient underwent revision surgery and plate fixation at a later date.Per further clarification from the surgeon, "the patient's bone quality is not strong," in the area where the pins were placed.No further information was provided or is available from the user facility.

• Brand Name: NAV PIN 3MM X 150MM CASE OF 10
• 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: 15518905
• Report Number: 3015967359-2022-01842
• Device Sequence Number: 20353192
• Product Code: HAW
• UDI-Device Identifier: 57613154107402
• UDI-Public: 57613154107402
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 10/25/2022

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
• Device Catalogue Number: 6007003150
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/07/2022
• Supplement Date Received by Manufacturer: 10/24/2022
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 10/25/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown