PHOTODYNAMIC BONE STABILIZATION SYSTEM

Additional Manufacturer Narrative

THIS MDR REPORT IS BASED ON THE RECLASSIFICATION OF A PREVIOUSLY REVIEWED COMPLAINT. FOLLOWUP INFORMATION PROVIDED BY THE USER: DURING THE TREATMENT OF A TRAUMATIC FIBULA FRACTURE IN GERMANY, THE DOCTOR REPORTED THAT THE 6.5MM BURR BROKE. PRIOR TO THAT, THE USER REPORTED THAT THEY HAD DIFFICULTY GETTING THE BURR INTO THE BONE CANAL. ALL PIECES OF THE DEVICE WERE REMOVED. THE PLANNED PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY. THE PATIENT OUTCOME WAS GOOD. RECORDS REVIEW: A REVIEW OF MANUFACTURING RECORDS WAS PERFORMED, AND FOUND THAT THE DEVICE MET SPECIFICATION AT THE TIME OF MANUFACTURE AND RELEASE. RETURNED PRODUCT EVALUATION: THE DECONTAMINATED DEVICE WAS RECEIVED ON FEBRUARY 25, 2022. DEVICE PHOTO-IMAGING WAS PERFORMED. THE PRODUCT EVALUATION PERFORMED IDENTIFIED THAT THE BREAK PATTERNS OBSERVED ARE CONSISTENT WITH OVERTORQUING OF THE DEVICE DURING USE. CONCLUSION: EXISTING EVIDENCE SUPPORTS THAT OVER-TORQUING OF THE DEVICE IS THE PROBABLE CAUSE OF THIS EVENT, ALTHOUGH THIS CANNOT BE DEFINITELY PROVEN WITH THE EVIDENCE AVAILABLE TO THE FIRM AT THIS TIME.

Description of Event or Problem

THIS MDR REPORT IS BASED ON THE RECLASSIFICATION OF A PREVIOUSLY REVIEWED COMPLAINT. A 6.5MM BUR BROKEN DURING A FIBULA CASE IN GERMANY. ALL INSTRUMENT PIECES WERE REMOVED FROM THE PATIENT. THE PATIENT OUTCOME WAS GOOD. NO HARM TO PATIENT.