UNKNOWN ORTHOSORB TRAUMA

Additional Manufacturer Narrative

THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.

Description of Event or Problem

IT WAS REPORTED DURING MULTIPLE CASES, THE PIN FRACTURED DURING USE. THE SURGEON REPORTED DIFFICULTY FINDING FRACTURED PIECES IN THE PATIENT AND SOME PIECES MAY BE RETAINED DUE TO THE COLOR OF THE PIN. SOME CASES HAVE BEEN COMPLETED USING ANOTHER DEVICE. NO FURTHER INFORMATION HAS BEEN PROVIDED REGARDING PATIENT OUTCOMES.