NA 2361-5035SRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327381597), received between Mar 10, 2022 and Jul 20, 2026 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJul 20, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "REMOVAL SURGERY WAS PERFORMED DUE TO SECONDARY FRACTURE OCCURRED IN THE FEMORAL TROCHANTERIC REGION IPSILATERAL TO THE SITE OF THE IMPLANTED NAIL AFTER BONE UNION WAS ACHIEVED."

  Patient problems: Limb Fracture

  MAUDE report 25883369 ↗
• MalfunctionMar 31, 2026Malposition of Device; Mechanical Jam

  AS REPORTED: "THE ADVANCED LOCKING SCREW INTERFERED WITH THE NAIL AND BECAME STUCK DURING INSERTION. AS IT COULD NOT BE ADVANCED ANY FURTHER, THE SCREW HEAD WAS CUT OFF AND ONLY THE SHAFT PORTION OF THE SCREW WAS LEFT IN THE PATIENT'S BODY TO COMPLETE THE PROCEDURE."

  Patient problems: Foreign Body In Patient

  MAUDE report 24749541 ↗
• MalfunctionMar 20, 2026Positioning Failure

  AS REPORTED: "AN ADVANCED SCREW 35MM WAS INSERTED INTO THE MOST PROXIMAL OBLIQUE HOLE, AND THE COUNTERBORING DRILL MANUAL WAS PERFORMED AS PER THE PROCEDURE MANUAL. HOWEVER, SINCE THE SCREW DID NOT ADVANCE SMOOTHLY, IT WAS REPLACED WITH A DIFFERENT SIZE SCREW, WHICH ALLOWED SUCCESSFUL INSERTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24653423 ↗
• MalfunctionFeb 2, 2026Mechanical Jam

  AS REPORTED: "THE ADVANCED SCREW BECAME STUCK WITH THE NAIL, MAKING REMOVAL DIFFICULT. SINCE IT COULD NOT BE REMOVED, WE INSERTED A SECOND DISTAL SCREW, REMOVED THE DEVICE, COMPLETED PLACEMENT UP TO THE END CAP, THEN EXTRACTED THE STACKED LATERAL FIXATION SCREW AND COMPLETED THE PROCEDURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24235051 ↗
• MalfunctionDec 11, 2025Malposition of Device; Malposition of Device

  THE DISTRIBUTOR CONTACTED SR THE DAY AFTER THE OPERATION TO REPORT THAT THE SURGEON HAD COMPLETED THE PROCEDURE WHILST BOTH DISTAL SCREWS REMAINED OUT OF POSITION. FOLLOWING THE OPERATION, SR MET WITH THE DOCTOR, BUT AS THE SURGEON MADE NO MENTION OF THIS, IT CANNOT BE DEFINITIVELY CONFIRMED WHETHER THE SCREWS WERE INDEED OUT OF POSITION. ADDITIONAL INFORMATION: SR VISITED THE DOCTOR TO CONFIRM THIS MATTER. THE SURGEON STATED THAT HE HAD NOT NOTICED THE INCORRECT SCREW POSITION DURING THE OPERATION; IT WAS ONLY DISCOVERED ON THE POSTOPERATIVE X-RAY. THE SCREW WAS NOT REINSERTED. THIS WAS BECAUSE THE SCREW HOLE HAD BECOME RELATIVELY LARGE IN RELATION TO THE CORTICAL BONE, RAISING CONCERNS ABOUT A SECONDARY FRACTURE AT THAT SITE. GIVEN THE PATIENT'S WIDE MEDULLARY CAVITY, THIS WAS INTERPRETED AS A STATE OF HIGH NAIL OCCUPANCY, AND IT WAS DECIDED NOT TO IMPOSE ANY WEIGHT-BEARING RESTRICTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23776341 ↗
• MalfunctionDec 11, 2025Malposition of Device; Malposition of Device

  THE DISTRIBUTOR CONTACTED SR THE DAY AFTER THE OPERATION TO REPORT THAT THE SURGEON HAD COMPLETED THE PROCEDURE WHILST BOTH DISTAL SCREWS REMAINED OUT OF POSITION. FOLLOWING THE OPERATION, SR MET WITH THE DOCTOR, BUT AS THE SURGEON MADE NO MENTION OF THIS, IT CANNOT BE DEFINITIVELY CONFIRMED WHETHER THE SCREWS WERE INDEED OUT OF POSITION. ADDITIONAL INFORMATION: SR VISITED THE DOCTOR TO CONFIRM THIS MATTER. THE SURGEON STATED THAT HE HAD NOT NOTICED THE INCORRECT SCREW POSITION DURING THE OPERATION; IT WAS ONLY DISCOVERED ON THE POSTOPERATIVE X-RAY. THE SCREW WAS NOT REINSERTED. THIS WAS BECAUSE THE SCREW HOLE HAD BECOME RELATIVELY LARGE IN RELATION TO THE CORTICAL BONE, RAISING CONCERNS ABOUT A SECONDARY FRACTURE AT THAT SITE. GIVEN THE PATIENT'S WIDE MEDULLARY CAVITY, THIS WAS INTERPRETED AS A STATE OF HIGH NAIL OCCUPANCY, AND IT WAS DECIDED NOT TO IMPOSE ANY WEIGHT-BEARING RESTRICTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23776340 ↗
• MalfunctionOct 16, 2025Mechanical Jam; Mechanical Jam

  AS REPORTED: "WHILE INSERTING AN ADVANCED LOCKING SCREW INTO THE PROXIMAL SCREW HOLE, THE SCREW BECAME STUCK AND WAS EXTRACTED WITH THE SCREWDRIVER SLEEVE. THE SCREW WAS ABLE TO BE EXTRACTED BUT WAS STUCK IN THE SCREWDRIVER SLEEVE. ANOTHER SCREW WAS INSERTED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23316937 ↗
• InjuryJun 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "UPON TIGHTENING THE END CAP AND FINAL CONFIRMATION WITH X-RAY, A FRACTURE LINE WAS DISCOVERED PROXIMAL TO THE MOST PROXIMAL LOCKING SCREW. THE SURGEON CONSIDERED PRESERVING IT AS IS, BUT BECAUSE OF THE RISK OF RE-FRACTURE, HE REPLACED THE NAIL WITH A LONG NAIL THAT PREPARED AS A BACKUP." ADDITIONALLY IT WAS REPORTED THAT THERE WAS A 45 MINUTE SURGICAL DELAY.

  Patient problems: Bone Fracture(s)

  MAUDE report 17072922 ↗
• MalfunctionMar 10, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED: "DURING AP SCREW INSERTION TO DISTAL OF THE TIBIA, THE SCREW BECAME STUCK IN THE NAIL. AN ATTEMPT WAS MADE TO REMOVE IT, BUT IT WAS DIFFICULT AND TOOK 30 MINUTES. THE SURGERY WAS COMPLETED WITHOUT INSERTING ANY SCREWS INTO THE HOLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13727591 ↗