BIOBRACE
Received Oct 20, 2025
Report 1320894-2025-00244 · MDR key 23335131
Device
Generic name
Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
Manufacturer
Rk ManufacturingCatalog number
BB23X30-FA
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, BB23X30-FA, BIOBRACE REINFORCED IMPLANT, FOOT AND ANKLE, 23 X 30 MM, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED, ¿WOUND HEALING ISSUE AFTER IMPLANTING BIOBRACE AS ONLAY FOR AN ACHILLES REPAIR.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. FURTHER ASSESSMENT INFORMATION HAS BEEN REQUESTED THROUGH A GOOD FAITH EFFORT; HOWEVER, TO DATE CONMED HAS NOT RECEIVED A RESPONSE. CONMED IS NOT AWARE OF THE RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTER¿S STATEMENT. THERE HAS BEEN NO REPORT OF MALFUNCTION OF ANY CONMED DEVICE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Additional Manufacturer Narrative
NEITHER THE DEVICE NOR PHOTOGRAPHIC EVIDENCE WAS PROVIDED. THEREFORE, THE REPORTED EVENT CANNOT BE VERIFIED. A DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. A TWO-YEAR LOT HISTORY REVIEW CANNOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 9 COMPLAINTS, REGARDING 9 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME (B)(4) DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED FOR THIS REPORTED FAILURE, THE RATE OF FAILURE WOULD BE (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED DO NOT USE THE BIOBRACE IMPLANT IF THE TEMPERATURE SENSITIVE DOT IS RED. VISUALLY INSPECT STERILE BARRIER SYSTEM(S) FOR ANY PACKAGE INTEGRITY ISSUES THAT COULD IMPACT DEVICE STERILITY PRIOR TO ASEPTIC PRESENTATION. DO NOT USE IF ANY BREACHES IN THE STERILE BARRIER SYSTEM(S) ARE FOUND. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.
Description of Event or Problem
THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, BB23X30-FA, BIOBRACE REINFORCED IMPLANT, FOOT AND ANKLE, 23 X 30 MM, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED, ¿WOUND HEALING ISSUE AFTER IMPLANTING BIOBRACE AS ONLAY FOR AN ACHILLES REPAIR.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. FURTHER ASSESSMENT INFORMATION HAS BEEN REQUESTED THROUGH A GOOD FAITH EFFORT; HOWEVER, TO DATE CONMED HAS NOT RECEIVED A RESPONSE. CONMED IS NOT AWARE OF THE RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTER¿S STATEMENT. THERE HAS BEEN NO REPORT OF MALFUNCTION OF ANY CONMED DEVICE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Additional Manufacturer Narrative
THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION AND REVIEW. HOWEVER, THE COMPLAINT INVESTIGATION IS NOT COMPLETE AT THIS TIME. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE COMPLAINT INVESTIGATION. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.