MAUDE Adverse Event Report: STRYKER INSTRUMENTS-FREIBURG NAV PIN 3MM X 150MM CASE OF 10

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	04/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(4) 2021 a total knee procedure was performed at the user facility, on (b)(6) 2021 the patient experienced a supra femoral fracture in the same area.The patient was treated for the fracture.There are no further known adverse consequences or medical intervention associated with the event.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results h3 other text: no product return per the customer.
Event or Problem Description
On (b)(6) 2021 a total knee procedure was performed at the user facility, on (b)(6) 2021 the patient experienced a suprafemoral fracture in the same area.The patient was treated for the fracture.There are no further known adverse consequences or medical intervention associated with the event.

• Brand Name: NAV PIN 3MM X 150MM CASE OF 10
• Common Device Name: NAV PIN 3MM X 150MM CASE OF 10
• Manufacturer (Section D): STRYKER INSTRUMENTS-FREIBURG; boetzingerstr. 41; freiburg MI D-791 11; GM D-79111
• MDR Report Key: 11757499
• Report Number: 3015967359-2021-00760
• Device Sequence Number: 3778363
• Product Code: HAW
• UDI-Device Identifier: 57613154107402
• UDI-Public: 57613154107402
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/17/2021

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?: No
• Operator of Device: No Information
• Device Catalogue Number: 6007003150
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 06/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention