REFLEX-HYBRID TEMPORARY FIXATION PIN STANDARD

Additional Manufacturer Narrative

METHOD: COMPLAINT HISTORY ANALYSIS, RISK ASSESSMENT. RESULTS: THERE HAVE BEEN 10 COMPLAINTS RELATED TO PIN FRACTURE FOR THIS DEVICE. PREVIOUS INVESTIGATIONS CONCLUDED THAT THE BREAKAGE WAS THE RESULT OF EXCESSIVE PIVOTING OR ANGULATIONS ON THE PINT DURING INSERTION INTO THE BONE. IN THIS EVENT, THERE WERE NO REPORTS OF ANY ADVERSE CONSEQUENCES OR SIGNIFICANT DELAYS IN SURGERY. CONCLUSION: A THOROUGH INVESTIGATION COULD NOT BE PERFORMED BECAUSE THE IMPLICATED DEVICE WAS NOT AVAILABLE FOR EVAL.

Description of Event or Problem

IT WAS REPORTED THAT "DR WAS REMOVING POSITIONING PIN FROM PT - PIN SNAPPED IN HALF".