BIOMET EBI BONE HEALING SYSTEM SFLX- 4 THERAPEUTIC TREATMENT COILETTE

Additional Manufacturer Narrative

ADDITIONAL INFORMATION IN THE FOLLOWING FIELDS - B4: DATE OF THIS REPORT, G3: DATE RECEIVED BY MANUFACTURER. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE DEVICE WAS NOT RETURNED TO EBI FOR EVALUATION. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED AS THE LOT NUMBER OF THE PRODUCT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT EXPERIENCED EXCRUCIATING PAIN AFTER 2 HOURS OF TREATMENT. THE PATIENT STATED THAT SHE IS FINE ALL DAY WITH NO PAIN BUT AFTER ABOUT 1 HOUR OF TREATMENT THE PAIN STARTS. THE PATIENT STATED THAT LAST NIGHT THE PAIN GOT SO BAD SHE HAD TO TAKE AN OXYCODONE. THE PATIENT HAS NOT DISCUSSED THE ISSUE WITH HER DOCTOR. THE PATIENT STATED SHE HAS NEVER SPOKEN WITH A SALES REPRESENTATIVE. PRODUCT SURVEILLANCE SPECIALIST (B)(6) GAVE THE PATIENT THE PHONE NUMBER FOR (B)(6) WHO IS LISTED AS THE SALES REPRESENTATIVE IN FILENET AND ADVISED THE PATIENT TO CONTACT THE SALES REP WITH THE CONCERN. NOTE: THIS INFORMATION WAS OBTAINED DURING SECOND ATTEMPT CALL FOR (B)(4). UPDATE 8/12: PER SECOND ATTEMPT CALL, THE PATIENT STATED THAT SHE HAD TO STOP USING THE UNIT DUE TO THE PAIN. THE PATIENT STATED THAT THE PAIN WAS EXCRUCIATING, RATED THE PAIN AN 8 OR 9 OUT OF 10. THE PATIENT REACHED OUT TO HER DOCTOR TO DISCUSS GETTING MORE PAIN MEDICATION BUT HER DOCTOR ADVISED HER TO STOP USING THE UNIT INSTEAD. THE PATIENT WAS ASKED IF SHE WOULD LIKE TO RETURN THE DEVICE FOR EVALUATION AND STATED SHE WOULD HAVE TO DISCUSS WITH HER DOCTOR, THE PATIENT MAY WANT TO RESUME TREATMENT AT SOME POINT. THE PATIENT WAS TRANSFERRED TO PAG TO DISCUSS HER OPTIONS.

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED TO HIGHRIDGE MEDICAL FOR EVALUATION; THEREFORE NO PRODUCT EVALUATION HAS BEEN CONDUCTED. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. HIGHRIDGE MEDICAL WILL CONTINUE TO MONITOR TRENDS.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT EXPERIENCED EXCRUCIATING PAIN AFTER 2 HOURS OF TREATMENT. THE PATIENT STATED THAT SHE IS FINE ALL DAY WITH NO PAIN BUT AFTER ABOUT 1 HOUR OF TREATMENT THE PAIN STARTS. THE PATIENT STATED THAT LAST NIGHT THE PAIN GOT SO BAD SHE HAD TO TAKE AN OXYCODONE. THE PATIENT HAS NOT DISCUSSED THE ISSUE WITH HER DOCTOR. THE PATIENT STATED SHE HAS NEVER SPOKEN WITH A SALES REPRESENTATIVE. PRODUCT SURVEILLANCE SPECIALIST (B)(6) GAVE THE PATIENT THE PHONE NUMBER FOR (B)(6) WHO IS LISTED AS THE SALES REPRESENTATIVE IN FILENET AND ADVISED THE PATIENT TO CONTACT THE SALES REP WITH THE CONCERN. NOTE THIS INFORMATION WAS OBTAINED DURING SECOND ATTEMPT CALL FOR (B)(4); CE-71533-2025. UPDATE 8/12: PER SECOND ATTEMPT CALL, THE PATIENT STATED THAT SHE HAD TO STOP USING THE UNIT DUE TO THE PAIN. THE PATIENT STATED THAT THE PAIN WAS EXCRUCIATING, RATED THE PAIN AN 8 OR 9 OUT OF 10. THE PATIENT REACHED OUT TO HER DOCTOR TO DISCUSS GETTING MORE PAIN MEDICATION BUT HER DOCTOR ADVISED HER TO STOP USING THE UNIT INSTEAD. THE PATIENT WAS ASKED IF SHE WOULD LIKE TO RETURN THE DEVICE FOR EVALUATION AND STATED SHE WOULD HAVE TO DISCUSS WITH HER DOCTOR, THE PATIENT MAY WANT TO RESUME TREATMENT AT SOME POINT. THE PATIENT WAS TRANSFERRED TO PAG TO DISCUSS HER OPTIONS.