ZIMMER BIOMET COMPLAINT (B)(4). DATE OF EVENT: THE EVENT OCCURRED SOMETIME IN (B)(6) 2020. MEDICAL PRODUCT: SCREW IN DISTAL FIBULA, THERAPY DATE: (B)(6) 2019, MEDICAL PRODUCT: BIOMET EBI BONE HEALING SYSTEM CATALOG: #1068234 SERIAL: # (B)(4), THERAPY DATE: UNKNOWN. THE CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. THE DEVICE HAS NOT BEEN RETURNED.
D
Patient 1
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SYMPTOMS FROM USING THE SFLX 1 COIL. THE PATIENT IS USING THE SFLX 1 COIL ON HIS LEFT ANKLE. THE PATIENT STATED THAT HE CAN'T USE THE DEVICE BECAUSE HE HAS NERVE DAMAGE DOWN THE LEFT LEG AND TO THE TOP OF THE FOOT. THE SFLX 1 COIL IS CONSTANTLY RUBBING ON THE PATIENT'S SKIN WHICH MAKES IT FEEL LIKE A BAD SUNBURN. THE PATIENT DID CONTACT HIS DOCTOR AND THE DOCTOR PROVIDED A SCRIPT TO SWITCH THE PATIENT TO A DIFFERENT DEVICE FOR TREATMENT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.