BIOBRACE
Report
- Report Number
- 1320894-2025-00244
- Event Type
- Malfunction
- Date Received
- October 20, 2025
- Report Date
- November 20, 2025
- Manufacturer
- RK MANUFACTURING
- Product Code
- OWW
- PMA / PMN Number
- K203267
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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.
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.
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.
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 320319 | BIOBRACE | MESH, SURGICAL, ABSORBABLE, ORTHOPAEDICS, REINFORCEMENT OF TENDON | OWW | RK MANUFACTURING | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |