AFFECTED ITEMS WERE RETURNED TO MANUFACTURER FOR EVALUATION. MANUFACTURER DETERMINED DURING PRELIMINARY INVESTIGATION THAT EPOXY BOND FAILURE WAS DUE TO INCONSISTENT EPOXY FILL AS A RESULT OF ASSEMBLY PROBLEMS CAUSING ANKLE TO INTERNALLY AND EXTERNALLY ROTATE. FINAL RESULTS ARE STILL PENDING COMPLETION OF EVALUATION. ROOT CAUSE ANALYSIS OF FAILURE MODE IS STILL UNDER INVESTIGATION AND AFFECTED ITEMS HAVE BEEN RETAINED. THIS DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER. ADDITIONAL INFORMATION FOLLOW-UP WILL BE SUBMITTED WHEN THE FOLLOWING INFO BECOMES AVAILABLE. A: PATIENT INFORMATION; CUSTOMER RELATIONS HAS REQUESTED THIS INFORMATION FROM THE CUSTOMER, PENDING RESPONSE.: THIS DEVICE IS CURRENTLY REGISTERED UNDER PROCODE BXB AS INDICATED IN. THIS DEVICE IS CURRENTLY PENDING 510(K) APPROVAL UNDER PROCODE PHL. (B)(4) REMEDIAL ACTION; ROOT CAUSE ANALYSIS IS STILL PENDING EVALUATION. NOTE TO FDA: SUBMITTED VIA PAPER SINCE PENDING ESG PRODUCTION ACCOUNT.
D
Patient 1
WHILE WALKING, PHYSICAL THERAPIST WAS TURNING A CORNER W/THE PATIENT AND NOTICED THE FOOT INTERNALLY ROTATED. THE PATIENT WAS LOWERED TO A CHAIR AND WAS SAFELY REMOVED FROM THE DEVICE. THE DEVICE WAS INSPECTED AND FOUND THAT THE EPOXY BOND ON THE ANKLE HAD BROKEN ALLOWING THE ANKLE TO ROTATE. THE PATIENT SUSTAINED NO INJURIES AND NO MEDICAL FOLLOW-UP OR INTERVENTION WAS NEEDED. NO PHYSICAL THERAPISTS, THERAPISTS, OR THIRD PERSONS HAVE BEEN AFFECTED OR INJURED.
N
Patient 1
ROOT CAUSE WAS HANDLING OF THE ANKLE ASSEMBLY DURING THE MANUFACTURING PROCESS BEFORE THE EPOXY ADHESIVE HAD CURED. REMEDIAL ACTION: DEVELOPED TOOLING AND FIXTURES TO PREVENT LOADS FROM BEING INTRODUCED DURING EPOXY CURE TIME. SINCE THIS FAILURE MODE REPRESENTS A LOW RISK OF INJURY THE CORRECTIVE ACTIONS WILL BE MADE AT THE NEXT ROUTINE SERVICE PERIOD.
D
Patient 1
THIS EVENT DID NOT LEAD TO AN INJURY AND THERE HAVE BEEN NO INJURIES REPORTED SINCE THE MDR WAS FILED.