Affixus® Natural Nail® 47-2496-160-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00889024505780), received between Aug 4, 2021 and Apr 29, 2026 — classified as 14 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (6 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2026Separation Problem

  IT WAS REPORTED FROM A CLINICAL STUDY THAT A PATIENT HAD UNDERWENT IM NAILING OF THE RIGHT PROXIMAL HUMERUS. SUBSEQUENT X-RAYS REVEALED EVIDENCE OF PROXIMAL SCREW LOOSENING AND PROTRUSION. THE PATIENT IS SCHEDULED FOR SCREW REMOVAL ON AN UNKNOWN DATE DUE TO PAIN FROM THE PROTRUDED SCREW. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Aseptic loosening; Loss of Range of Motion; Pain

  MAUDE report 25025527 ↗
• MalfunctionMar 30, 2026Separation Problem

  IT WAS REPORTED FROM A CLINICAL STUDY THAT THE PATIENT UNDERWENT AN INITIAL RIGHT PROXIMAL HUMERAL NAILING, AND SCREW LOOSENING WAS INCIDENTALLY IDENTIFIED ON RADIOGRAPHS APPROXIMATELY 6 WEEKS POST-IMPLANTATION. SUBSEQUENTLY, THE PATIENT EXPERIENCED A FALL AND SUSTAINED A FRACTURE OF THE LEFT HUMERUS; THE LEFT SIDE HAD NO IMPLANTS AND WAS MANAGED CONSERVATIVELY WITHOUT SURGICAL INTERVENTION. DURING THE NEXT FOLLOW-UP VISIT APPROXIMATELY 3 WEEKS LATER, RADIOGRAPHS SHOWED LOOSENING OF A SECOND SCREW, WHILE THE FIRST SCREW REMAINED UNCHANGED. NO ACTION WAS TAKEN AS THE PATIENT WAS NOT REPORTING PAIN OR DISCOMFORT. THE PATIENT DID NOT REQUIRE SURGICAL INTERVENTION AND REMAINED ASYMPTOMATIC. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24729273 ↗
• MalfunctionFeb 5, 2026Separation Problem

  IT WAS REPORTED THAT ONE PROXIMAL SCREW BACKED OUT APPROXIMATELY 2 MONTHS POSTOPERATIVELY FOLLOWING AN INTRAMEDULLARY NAILING PROCEDURE. THE PATIENT WAS MONITORED, AND NO REVISION WAS PLANNED. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24274669 ↗
• MalfunctionJul 24, 2025Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SURGERY WITH ANN NAIL. SUBSEQUENTLY, 9 DAYS POST IMPLANTATION, SURGEON FOUND THREE OF THE PROXIMAL SCREWS WERE BACKED OUT FROM THE PROPER POSITION. THE SURGEON WILL KEEP AN EYE ON THE PATIENT CONDITION AS WELL, AS NO REVISION WILL BE PLANNED SO FAR. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22586999 ↗
• MalfunctionAug 21, 2024Separation Problem; Separation Problem

  IT WAS REPORTED THAT AFTER 9 MONTHS FROM THE INITIAL IMPLANTATION ONE OF THE PROXIMAL SCREWS WAS BACKED OUT FROM THE PROPER POSITION. THE PATIENT'S HEALTH IS FINE, THE SCREW HAS NOT BEEN REMOVED AND NO REVISION SURGERY HAS BEEN PERFORMED. THERE IS NO REPORTED HARM OR INJURY TO THE PATIENT, HOWEVER THIS MALFUNCTION HAS CAUSED A SERIOUS INJURY IN THE PAST. DUE DILIGENCE HAS BEEN COMPLETED FOR THIS COMPLAINT; TO DATE ALL AVAILABLE ADDITIONAL INFORMATION HAS BEEN RECEIVED.

  Patient problems: Failure of Implant

  MAUDE report 20018021 ↗
• InjuryJun 6, 2024Separation Problem; Separation Problem

  IT WAS REPORTED THAT A PATIENT HAD A REVISION SURGERY NINE (9) MONTHS AFTER INITIAL IMPLANTATION DUE TO A PROXIMAL SCREW THAT WAS BACKED OUT FROM THE PROPER POSITION. THE PATIENT COMPLAINED OF PAIN AND A REVISION SURGERY WAS PERFORMED TO REMOVE THE MIGRATED SCREW. DUE DILIGENCE HAS BEEN COMPLETED FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 19475393 ↗
• MalfunctionMay 14, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT FOUR WEEKS POST-IMPLANTATION, SURGEON FOUND ONE OF THE PROXIMAL SCREWS WAS BACKED OUT FROM THE PROPER POSITION. THE SURGEON WILL KEEP AN EYE ON THE PATIENT CONDITION MOVING FORWARD, AS NO REVISION WILL BE PLANNED AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19313590 ↗
• InjuryAug 30, 2023Migration; Migration

  IT WAS REPORTED THAT FIVE WEEKS POST-IMPLANTATION ONE OF THE SCREWS BACKED OUT FROM THE PROPER POSITION. THE PATIENT COMPLAINED OF PAIN AND REVISION SURGERY WAS PERFORMED TO REMOVE THE MIGRATED SCREW. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 17648582 ↗
• InjuryJul 20, 2023Migration; Migration

  IT WAS REPORTED THAT PROXIMAL SCREW BACKED OUT FROM THE PROPER POSITION AFTER FOUR (4) WEEKS FROM THE INITIAL SURGERY. NO REVISION PLANNED SO FAR. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17358979 ↗
• InjuryApr 3, 2023Migration; Migration

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant

  MAUDE report 16662835 ↗
• InjuryNov 29, 2022

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant

  MAUDE report 15876009 ↗
• InjuryJun 30, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE OF THE RIGHT HIP APPROXIMATELY SIX (6) MONTHS POST IMPLANTATION DUE TO MIGRATION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Failure of Implant

  MAUDE report 14869515 ↗
• InjuryMay 11, 2022Migration or Expulsion of Device; Expulsion; Migration or Expulsion of Device; Expulsion

  IT WAS REPORTED THAT 6 WEEKS AFTER IMPLANTATION, PATIENT EXPERIENCED HUMERAL HEAD NECROSIS. PROXIMAL SCREW NEXT TO THE SCREW HOLE HAD MIGRATED. REVISION SURGERY HAS BEEN PLANNED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED YET.

  Patient problems: Failure of Implant; Necrosis

  MAUDE report 14352013 ↗
• InjuryMar 4, 2022Mechanical Problem; Material Integrity Problem; Mechanical Problem; Material Integrity Problem

  IT WAS REPORTED THAT OPERATION WAS PERFORMED WITH ANN NAIL SYSTEM. AFTER 4 MONTHS FROM THE INITIAL, SURGEON FOUND A SCREW OF THE PROXIMAL SCREWS WAS BACKED OUT FROM THE PROPER POSITION. THE SURGEON KEEP AN EYE ON THE PATIENT CONDITION AS WELL AS NO REVISION WILL BE PLANNED SO FAR. PATIENT INVOLVEMENT. NO FURTHER OUTCOME.

  Patient problems: Insufficient Information; Joint Dislocation

  MAUDE report 13666837 ↗
• InjuryFeb 2, 2022Migration or Expulsion of Device; Patient Device Interaction Problem; Migration or Expulsion of Device; Patient Device Interaction Problem

  IT WAS REPORTED THAT OPERATION WAS PERFORMED WITH ANN NAIL. AFTER 3 WEEKS FROM THE INITIAL, SURGEON FOUND #2 SCREW OF THE PROXIMAL SCREWS WAS BACKED OUT FROM THE PROPER POSITION. THEREFORE, REVISION SURGERY WAS PERFORMED AND THE MIGRATED SCREW WAS REINSERTED AND RETIGHTENED THE CORELOCK. OUTCOME - REVISION DUE TO MIGRATION.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 13421424 ↗
• MalfunctionJan 4, 2022Mechanical Problem; Patient Device Interaction Problem; Mechanical Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AFTER INITIAL SURGERY OF THE ANN NAIL SYSTEM ONE OF THE ANN BLUNT SCREWS BACKED OUT.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13151581 ↗
• InjuryDec 22, 2021Mechanical Problem; Migration or Expulsion of Device; Mechanical Problem; Migration or Expulsion of Device

  IT WAS REPORTED THAT AFTER INITIAL SURGERY THE SURGEON FOUND THAT ONE OF THE PROXIMAL SCREWS WAS BACKED OUT. NO REVISION PLANNED SO FAR.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13060085 ↗
• InjuryNov 25, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  INVESTIGATION RESULTS ARE NOW AVAILABLE.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12873602 ↗
• MalfunctionSep 28, 2021Mechanical Problem; Loosening of Implant Not Related to Bone-Ingrowth; Mechanical Problem; Loosening of Implant Not Related to Bone-Ingrowth

  INVESTIGATION HAS BEEN COMPLETED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 12539663 ↗
• InjurySep 15, 2021Mechanical Problem; Mechanical Problem

  PATIENT WAS IMPLANTED WITH ANN NAIL SYSTEM ON THE RIGHT SIDE. TWO WEEKS POST THE SURGERY, THE SURGEON NOTICED THAT THE 1ST AND THE 2ND SCREW HAD BACKED OUT FROM THEIR POSITION AND HENCE A REVISION SURGERY WAS PERFORMED DURING WHICH ALL THE PRODUCTS IMPLANTED DURING THE INITIAL SURGERY WERE EXPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 12473099 ↗
• InjuryAug 4, 2021Mechanical Problem; Migration; Mechanical Problem; Migration

  PATIENT WAS IMPLANTED WITH ANN NAIL SYSTEM ON AN UNKNOWN SIDE. A MONTH AFTER THE INITIAL SURGERY, THE SURGEON NOTICED THAT ONE OF THE PROXIMAL SCREW HAD MIGRATED FROM ITS POSITION. THE SURGEON IS MONITORING THE PATIENT'S CONDITION AND A REVISION SURGERY HAS NOT YET BEEN PLANNED. THE TORQUE DRIVER WAS USED TO ENGAGE THE CORELOCK, FURTHERMORE NON-TORQUE DRIVER WAS USED TO TIGHTEN MORE AFTER USING THE TORQUE DRIVER.

  Patient problems: Insufficient Information

  MAUDE report 12272832 ↗