BIOMET EBI BONE HEALING SYSTEM
Received Aug 19, 2025
Report 0002242816-2025-00098 · MDR key 22839869
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Female
- Burn(s)
- Burn(s)
Narrative
Additional Manufacturer Narrative
CORRECTIONS IN B4: H6: EVALUATION CODES, H3. ADDITIONAL INFORMATION IN H6: COMPONENT CODE AND H10: ADDITIONAL NARRATIVE. ESTIMATED DATE OF THE EVENT B3: UNKNOWN. THE BHS UNIT WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION OF THE CUSTOMER¿S RETURNED PRODUCT WAS PERFORMED. INCLUDED WAS A BHS CONTROLLER PART NO. 1068234 WITH SERIAL NO. (B)(6) RECEIVED IN A SHIPPING BOX APPEARING TO BE IN GOOD CONDITION FROM THE VISUAL/COSMETIC POINT OF VIEW. THE FAILURE WAS NOT CONFIRMED FOR THE REPORTED CONDITION OF "PATIENT BURNED BY BHS". THE CONTROLLER WAS TESTED AND OPERATES AS INTENDED. REVIEW OF COMPLAINT HISTORY IDENTIFIED (6) TOTAL COMPLAINTS FROM (JUL 22, 2024) TO (JUL 22, 2025) FOR PN (1068234) AND EVENTS RELATED TO (BURN). KEYWORD SEARCH CRITERIA: (COMPLAINT CODE: MEDICAL: BURN) THE SEARCH COULD NOT BE SPECIFIED FURTHER BECAUSE THE MAIN COMPLAINT WAS BURN. REVIEW OF THE INFORMATION PROVIDED BY THE CUSTOMER AND THE FINDINGS FROM THE INVESTIGATION INDICATED THAT NO PHYSICAL AND/OR DEVICE FUNCTIONAL CONDITION COULD BE FOUND THAT COULD BE CONSIDERED A CAUSAL FACTOR FOR THE REPORTED COMPLAINT OF "BURN". NO FAILURE AND/OR FAULT CONDITION COULD BE FOUND AND CONFIRMED. THEREFORE, NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. DEVICE USAGE: THIS DEVICE WAS USED FOR TREATMENT. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT. HIGHRIDGE MEDICAL WILL CONTINUE TO MONITOR FOR TREND.
Description of Event or Problem
IT WAS REPORTED BY THE PATIENT THAT THE UNIT BURNED HER FOOT. THIS HAPPENED IN DECEMBER OR EARLY JANUARY. THE PATIENT REPORTED IT TO HER DOCTOR AND WAS PRESCRIBED HONEY CREAM. THE CREAM WAS RECALLED, AND THE DOCTOR GAVE THE PATIENT A SAMPLE OF SANTYL 30 GRAMS CREAM. THE BURN HEALED, AND THE PATIENT REQUESTED TO RESUME TREATMENT. IT WAS LATER REPORTED THAT THE BURN IS NOW COMPLETELY HEALED, THERE IS JUST A SCAR REMAINING. THE PATIENT ALSO STATED THAT THE DEVICE HAS EXPOSED WIRES ON THE CONTROLLER, BUT SHE HAD NOT NOTICED THE CONTROLLER GETTING WARM AFTER RESUMING TREATMENT. A REPLACEMENT CONTROLLER WAS SHIPPED TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.
Description of Event or Problem
IT WAS REPORTED BY THE PATIENT THAT THE UNIT BURNED HER FOOT. THIS HAPPENED IN (B)(6) OR EARLY (B)(6). THE PATIENT REPORTED IT TO HER DOCTOR AND WAS PRESCRIBED HONEY CREAM. THE CREAM WAS RECALLED, AND THE DOCTOR GAVE THE PATIENT A SAMPLE OF SANTYL 30 GRAMS CREAM. THE BURN HEALED, AND THE PATIENT REQUESTED TO RESUME TREATMENT. IT WAS LATER REPORTED THAT THE BURN IS NOW COMPLETELY HEALED, THERE IS JUST A SCAR REMAINING. THE PATIENT ALSO STATED THAT THE DEVICE HAS EXPOSED WIRES ON THE CONTROLLER, BUT SHE HAD NOT NOTICED THE CONTROLLER GETTING WARM AFTER RESUMING TREATMENT. A REPLACEMENT CONTROLLER WAS SHIPPED TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.
Additional Manufacturer Narrative
SECTION B3: THE DATE OF THE EVENT IS UNKNOWN. PER THE PATIENT, THE EVENT OCCURRED EITHER IN (B)(6) 2024 OR EARLY (B)(6) 2025. 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.