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

Catalog Number	6007003150
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/20/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the surgeon whom performed the procedure at the user facility the ortholock navigation pin insertion was laterally displaced and became transcortical.Sometime after the procedure the patient's femur broke.Per the surgeon there is no allegation of a malfunction by the ortholock pin or any medical device used during the procedure.Medical intervention was needed to treat the broken femur.There are no further known adverse consequences or medical intervention associated with the procedure.
Event or Problem Description
Per the surgeon whom performed the procedure at the user facility the ortholock navigation pin insertion was laterally displaced and became transcortical.Sometime after the procedure the patient's femur broke.Per the surgeon there is no allegation of a malfunction by the ortholock pin or any medical device used during the procedure.Medical intervention was needed to treat the broken femur.There are no further known adverse consequences or medical intervention associated with the procedure.
Additional Manufacturer Narrative
Additional information added for d4, d10, h3, h4.Device evaluation: follow-up report submitted to document device evaluation results.H3 other text : not available.

• 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-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 10864133
• Report Number: 0001811755-2020-03213
• Device Sequence Number: 14112258
• 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): 12/14/2020

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?: No
• Operator of Device: No Information
• Device Catalogue Number: 6007003150
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 12/11/2020
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 12/14/2020
• 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: Required Intervention