BIOMET EBI BONE HEALING SYSTEM
Received Oct 23, 2025
Report 0002242816-2025-00129 · MDR key 23365967
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
82 YR · Female
- Pain
- Pain
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION IN THE FOLLOWING FIELDS - B4: DATE OF THIS REPORT, G3: DATE RECEIVED BY MANUFACTURER. H2: FOLLOW UP TYPE, H3: DEVICE MANUFACTURE DATE, H6: EVALUATION CODES. CORRECTED DATA IN THE FOLLOWING FIELDS - D2: COMMON DEVICE NAME, D3: CATALOG NUMBER, H6: DEVICE CODE AND COMPONENT CODE. SECTION B3: AS THE DAY OF THE EVENT IS UNKNOWN, THE EVENT DATE IS ESTIMATED AS SEPTEMBER OF 2025. 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 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.
Description of Event or Problem
THE SALES REP ADVISED THAT THE PATIENT IS EXPERIENCING PAIN AFTER 4 HOURS WHILE USING THE BHS. THE PATIENT WAS CALLED AND ADVISED THAT SHE HAD ANKLE PAIN AND WORE IT FOR 10 HOURS. THE PATIENT DID NOT CALL THE DOCTOR, SHE CALLED THE SALES REP, WAS ADVISED TO DO A TIME TEST. NO NEW PRODUCT WAS SHIPPED TO THE PATIENT. NO FURTHER CONSEQUENCES ARE REPORTED. THE BHS UNIT AND SFLX COILETTE WERE NOT RETURNED FOR FURTHER EVALUATION.
Description of Event or Problem
THE SALES REP ADVISED THAT THE PATIENT IS EXPERIENCING PAIN AFTER 4 HOURS WHILE USING THE BHS. THE PATIENT WAS CALLED AND ADVISED THAT SHE HAD ANKLE PAIN AND WORE IT FOR 10 HOURS. THE PATIENT DID NOT CALL THE DOCTOR, SHE CALLED THE SALES REP, WAS ADVISED TO DO A TIME TEST. NO NEW PRODUCT WAS SHIPPED TO THE PATIENT.
Additional Manufacturer Narrative
WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW UP REPORT WILL BE SENT.