BIOMET EBI BONE HEALING SYSTEM

Description of Event or Problem

IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PATIENT EXPERIENCED PAIN IN THE KNEE WHILE USING THE BHS ASSEMBLY. THE PATIENT DID NOT INDICATE THE PAIN LEVEL.

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 WERE 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.

Additional Manufacturer Narrative

CORRECTIONS IN B4: DATE OF THE REPORT. ADDITIONAL INFORMATION IN B5: EVENT DESCRIPTION, D8-9, G3, H2 AND H3, H6: COMPONENT, INVESTIGATION TYPE, FINDINGS, AND CONCLUSIONS AND H10: ADDITIONAL NARRATIVE. 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 COMPLIANCE DATA WAS DOWNLOADED FOR THE BHS CONTROLLER, AND A COPY IS INCLUDED IN THE COMPLAINT ATTACHMENTS SECTION. THE COMPLIANCE DATA INDICATES THAT THE UNIT TREATED FOR 3 HOURS AND WAS USED FOR 1 DAY. THE DHR REVIEW INDICATES THAT THE UNIT WAS MANUFACTURED ON JUNE 11, 2025. THE UNIT RAN BURN-IN WITH SAMPLE COIL STAND ALONE FOR TEN (10) HOURS WITH AC ADAPTER AND (10) HOURS WITHOUT AN AC ADAPTER WITHOUT A PROBLEM. NO ABNORMAL CONDITION REPORTED ON DHR AND COMPLIANCE DATA. THE FAILURE WAS NOT CONFIRMED FOR THE REPORTED CONDITION OF "PAIN IN KNEE FROM BHS". THE CONTROLLER WAS TESTED AND OPERATED AS INTENDED. REVIEW OF COMPLAINT HISTORY IDENTIFIED (25) TOTAL COMPLAINTS FROM (JULY 3, 2024) TO (JULY 3, 2025) FOR PN: (1068234) AND EVENTS RELATED TO (PAIN). KEYWORD SEARCH CRITERIA: (COMPLAINT CODE: MEDICAL: PAIN) THE SEARCH COULD NOT BE SPECIFIED FURTHER BECAUSE THE MAIN COMPLAINT WAS PAIN. 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 AND THAT COULD BE CONSIDERED A CAUSAL FACTOR FOR THE REPORTED COMPLAINT OF "PAIN". NO FAILURE AND/OR FAULT CONDITIONS COULD BE FOUND AND CONFIRMED. THEREFORE, NO FURTHER ACTIONS ARE REQUIRED CURRENTLY. 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.

Description of Event or Problem

IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PATIENT EXPERIENCED PAIN IN THE KNEE WHILE USING THE BHS ASSEMBLY. THE PATIENT DID NOT INDICATE THE PAIN LEVEL. NO FURTHER CONSEQUENCES WERE REPORTED. THE BHS ASSEMBLY AND COIL WERE RETURNED FOR EVALUATION.