NA 204.028Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982145420), received between Aug 16, 2018 and Aug 16, 2018 — classified as 5 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT SUFFERED A MOTORCYCLE ACCIDENT ON (B)(6) 2008, RESULTING IN AN OPEN FRACTURE IN THE TIBIA AND FIBULA OF THE RIGHT LOWER LEG. ON (B)(6) 2008, THE PATIENT UNDERWENT SURGERY BY PLACING 5 SCREWS AND ONE UNKNOWN SYNTHES PLATE ON THE RIGHT FIBULA AND A UNIVERSAL TIBIAL NAIL AND 4 LOCKING BOLTS ON THE RIGHT TIBIA. ON AN UNKNOWN DATE, IT WAS REPORTED THAT THE PATIENT HAD ALMOST UNBEARABLE PAIN DAILY AND HIS PHYSICAL CONDITION DID NOT IMPROVE. HIS ANKLE REMAINED INFLAMED WITHOUT SIGNS OF IMPROVEMENT. IT WAS DISCOVERED THAT A LOCKING BOLT, USED WITH THE UNIVERSAL TIBIAL NAIL, HAD BROKEN. ON (B)(6) 2008 THE PATIENT UNDERWENT A REVISION TO REMOVE THE BROKEN LOCKING BOLT AND A NEW LOCKING BOLT WAS IMPLANTED. APPROXIMATELY 6 MONTHS LATER ((B)(6) 2009) THE PATIENT FELT UNBEARABLE PAIN AND ON (B)(6) 2009, CT SCAN CONCLUSION WAS THAT THE UNIVERSAL TIBIAL NAIL HAD BROKEN. CT CONCLUSION RESULTS STATED THAT THE PATIENT HAD CONTROL OF OSTEOSYNTHESIS OF TIBIAL AND FIBULAR FRACTURES, WITH DISTAL TIBIAL-FIBULAR TRACES, AND IN THE MIDDLE THIRD OF THE TIBIAL SHAFT. NON-REACTIVE CONSOLIDATION DELAY OF TIBI

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 7790517 ↗
• InjuryAug 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT SUFFERED A MOTORCYCLE ACCIDENT ON (B)(6) 2008, RESULTING IN AN OPEN FRACTURE IN THE TIBIA AND FIBULA OF THE RIGHT LOWER LEG. ON (B)(6) 2008, THE PATIENT UNDERWENT SURGERY BY PLACING 5 SCREWS AND ONE UNKNOWN SYNTHES PLATE ON THE RIGHT FIBULA AND A UNIVERSAL TIBIAL NAIL AND 4 LOCKING BOLTS ON THE RIGHT TIBIA. ON AN UNKNOWN DATE, IT WAS REPORTED THAT THE PATIENT HAD ALMOST UNBEARABLE PAIN DAILY AND HIS PHYSICAL CONDITION DID NOT IMPROVE. HIS ANKLE REMAINED INFLAMED WITHOUT SIGNS OF IMPROVEMENT. IT WAS DISCOVERED THAT A LOCKING BOLT, USED WITH THE UNIVERSAL TIBIAL NAIL, HAD BROKEN. ON (B)(6) 2008 THE PATIENT UNDERWENT A REVISION TO REMOVE THE BROKEN LOCKING BOLT AND A NEW LOCKING BOLT WAS IMPLANTED. APPROXIMATELY 6 MONTHS LATER ((B)(6) 2009) THE PATIENT FELT UNBEARABLE PAIN AND ON (B)(6) 2009, CT SCAN CONCLUSION WAS THAT THE UNIVERSAL TIBIAL NAIL HAD BROKEN. CT CONCLUSION RESULTS STATED THAT THE PATIENT HAD CONTROL OF OSTEOSYNTHESIS OF TIBIAL AND FIBULAR FRACTURES, WITH DISTAL TIBIAL-FIBULAR TRACES, AND IN THE MIDDLE THIRD OF THE TIBIAL SHAFT. NON-REACTIVE CONSOLIDATION DELAY OF TIBI

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 7790483 ↗
• InjuryAug 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT SUFFERED A MOTORCYCLE ACCIDENT ON (B)(6) 2008, RESULTING IN AN OPEN FRACTURE IN THE TIBIA AND FIBULA OF THE RIGHT LOWER LEG. ON (B)(6) 2008, THE PATIENT UNDERWENT SURGERY BY PLACING 5 SCREWS AND ONE UNKNOWN SYNTHES PLATE ON THE RIGHT FIBULA AND A UNIVERSAL TIBIAL NAIL AND 4 LOCKING BOLTS ON THE RIGHT TIBIA. ON AN UNKNOWN DATE, IT WAS REPORTED THAT THE PATIENT HAD ALMOST UNBEARABLE PAIN DAILY AND HIS PHYSICAL CONDITION DID NOT IMPROVE. HIS ANKLE REMAINED INFLAMED WITHOUT SIGNS OF IMPROVEMENT. IT WAS DISCOVERED THAT A LOCKING BOLT, USED WITH THE UNIVERSAL TIBIAL NAIL, HAD BROKEN. ON (B)(6) 2008 THE PATIENT UNDERWENT A REVISION TO REMOVE THE BROKEN LOCKING BOLT AND A NEW LOCKING BOLT WAS IMPLANTED. APPROXIMATELY 6 MONTHS LATER ((B)(6) 2009) THE PATIENT FELT UNBEARABLE PAIN AND ON (B)(6) 2009, CT SCAN CONCLUSION WAS THAT THE UNIVERSAL TIBIAL NAIL HAD BROKEN. CT CONCLUSION RESULTS STATED THAT THE PATIENT HAD CONTROL OF OSTEOSYNTHESIS OF TIBIAL AND FIBULAR FRACTURES, WITH DISTAL TIBIAL-FIBULAR TRACES, AND IN THE MIDDLE THIRD OF THE TIBIAL SHAFT. NON-REACTIVE CONSOLIDATION DELAY OF TIBI

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 7790446 ↗
• InjuryAug 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT SUFFERED A MOTORCYCLE ACCIDENT ON (B)(6) 2008, RESULTING IN AN OPEN FRACTURE IN THE TIBIA AND FIBULA OF THE RIGHT LOWER LEG. ON (B)(6) 2008, THE PATIENT UNDERWENT SURGERY BY PLACING 5 SCREWS AND ONE UNKNOWN SYNTHES PLATE ON THE RIGHT FIBULA AND A UNIVERSAL TIBIAL NAIL AND 4 LOCKING BOLTS ON THE RIGHT TIBIA. ON AN UNKNOWN DATE, IT WAS REPORTED THAT THE PATIENT HAD ALMOST UNBEARABLE PAIN DAILY AND HIS PHYSICAL CONDITION DID NOT IMPROVE. HIS ANKLE REMAINED INFLAMED WITHOUT SIGNS OF IMPROVEMENT. IT WAS DISCOVERED THAT A LOCKING BOLT, USED WITH THE UNIVERSAL TIBIAL NAIL, HAD BROKEN. ON (B)(6) 2008 THE PATIENT UNDERWENT A REVISION TO REMOVE THE BROKEN LOCKING BOLT AND A NEW LOCKING BOLT WAS IMPLANTED. APPROXIMATELY 6 MONTHS LATER ((B)(6) 2009) THE PATIENT FELT UNBEARABLE PAIN AND ON (B)(6) 2009, CT SCAN CONCLUSION WAS THAT THE UNIVERSAL TIBIAL NAIL HAD BROKEN. CT CONCLUSION RESULTS STATED THAT THE PATIENT HAD CONTROL OF OSTEOSYNTHESIS OF TIBIAL AND FIBULAR FRACTURES, WITH DISTAL TIBIAL-FIBULAR TRACES, AND IN THE MIDDLE THIRD OF THE TIBIAL SHAFT. NON-REACTIVE CONSOLIDATION DELAY OF TIBI

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 7790389 ↗
• InjuryAug 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT SUFFERED A MOTORCYCLE ACCIDENT ON (B)(6) 2008, RESULTING IN AN OPEN FRACTURE IN THE TIBIA AND FIBULA OF THE RIGHT LOWER LEG. ON (B)(6) 2008, THE PATIENT UNDERWENT SURGERY BY PLACING 5 SCREWS AND ONE UNKNOWN SYNTHES PLATE ON THE RIGHT FIBULA AND A UNIVERSAL TIBIAL NAIL AND 4 LOCKING BOLTS ON THE RIGHT TIBIA. ON AN UNKNOWN DATE, IT WAS REPORTED THAT THE PATIENT HAD ALMOST UNBEARABLE PAIN DAILY AND HIS PHYSICAL CONDITION DID NOT IMPROVE. HIS ANKLE REMAINED INFLAMED WITHOUT SIGNS OF IMPROVEMENT. IT WAS DISCOVERED THAT A LOCKING BOLT, USED WITH THE UNIVERSAL TIBIAL NAIL, HAD BROKEN. ON (B)(6) 2008 THE PATIENT UNDERWENT A REVISION TO REMOVE THE BROKEN LOCKING BOLT AND A NEW LOCKING BOLT WAS IMPLANTED. APPROXIMATELY 6 MONTHS LATER ((B)(6) 2009) THE PATIENT FELT UNBEARABLE PAIN AND ON (B)(6) 2009, CT SCAN CONCLUSION WAS THAT THE UNIVERSAL TIBIAL NAIL HAD BROKEN. CT CONCLUSION RESULTS STATED THAT THE PATIENT HAD CONTROL OF OSTEOSYNTHESIS OF TIBIAL AND FIBULAR FRACTURES, WITH DISTAL TIBIAL-FIBULAR TRACES, AND IN THE MIDDLE THIRD OF THE TIBIAL SHAFT. NON-REACTIVE CONSOLIDATION DELAY OF TIBI

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 7790282 ↗