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

Model Number	6007-003-150
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device discarded by facility.
Event or Problem Description
It was reported that during a uka surgery, the device was inserted into the femur, but it was difficult to enter.The image was checked and the pin was bent.When the health care professional tried to remove it, the pin broke from the thread at the tip.The operation was completed with an alternative pin.At the time of creating a peg hole after cutting the femur, the peg hole was further deepened with a hanson pin drill, and the broken part was extracted with forceps.It was reported that there were no parts of the pin left in the patient.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.H3 other text : device not available.
Event or Problem Description
It was reported that during a uka surgery, the device was inserted into the femur, but it was difficult to enter.The image was checked and the pin was bent.When the health care professional tried to remove it, the pin broke from the thread at the tip.The operation was completed with an alternative pin.At the time of creating a peg hole after cutting the femur, the peg hole was further deepened with a hanson pin drill, and the broken part was extracted with forceps.It was reported that there were no parts of the pin left in the patient.

• Brand Name: NAV PIN 3MM X 150MM 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: 9139869
• Report Number: 0001811755-2019-03137
• Device Sequence Number: 13898876
• Product Code: HAW
• UDI-Device Identifier: 37613154107408
• UDI-Public: 37613154107408
• Combination Product (Y/N): N
• 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): 01/22/2020

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 Model Number: 6007-003-150
• Device Catalogue Number: 6007003150
• Device Lot Number: L40580
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/10/2019
• Supplement Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 01/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1