NA 03.045.020Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10886982296139), received between Sep 17, 2021 and Sep 29, 2026 — classified as 37 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (25 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Nonstandard Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50940652 ↗
• MalfunctionMay 7, 2026Device-Device Incompatibility

  WHEN DRILLING THE PROXIMAL MEDIAL TO LATERAL HOLES ON THE NAIL, THE CARBON FIBER AIMING ARM WAS MISALIGNED, LEADING TO A FAIL IN DRILLING USING THE INSTRUMENTATION. THIS CAUSED DELAY IN SURGERY TIME. NO COMPLICATIONS FOR PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25112111 ↗
• MalfunctionMar 11, 2026Material Deformation

  IT WAS REPORTED THAT THERE WAS A BENT DRILL SLEEVE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24567832 ↗
• MalfunctionOct 15, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT OSTEOSYNTHESIS FOR FEMORAL TROCHANTERIC FRACTURES. DURING THE PRELIMINARY DRY CHECK, THERE WAS INTERFERENCE WITH THE DRILL WHEN INSERTING THE TFNA 130°-260MM LEFT LONG USING THE 260 DISTAL AIMING DEVICES. EVEN DURING ADJUSTMENT, THE DRILL BIT INTERFERED WITH THE PROXIMAL SIDE OF THE MOST PROXIMAL HOLE IN THE NAIL. FURTHERMORE, THERE WAS INTERFERENCE WHEN THE DEVICES WERE LOCKED AFTER ADJUSTMENT, LEADING TO SUSPICION THAT THERE MAY BE A MALFUNCTION IN THE DEVICES. AFTER ADJUSTMENT DURING THE DRY CHECK BEFORE INSERTION THERE WAS NO INTERFERENCE, BUT WHEN THE DEVICES WERE LOCKED, INTERFERENCE OCCURRED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES OF DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23281490 ↗
• MalfunctionOct 15, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT OSTEOSYNTHESIS FOR FEMORAL TROCHANTERIC FRACTURES. DURING THE PRELIMINARY DRY CHECK, THERE WAS INTERFERENCE WITH THE DRILL WHEN INSERTING THE TFNA 130°-260MM LEFT LONG USING THE 260 DISTAL AIMING DEVICES. EVEN DURING ADJUSTMENT, THE DRILL BIT INTERFERED WITH THE PROXIMAL SIDE OF THE MOST PROXIMAL HOLE IN THE NAIL. FURTHERMORE, THERE WAS INTERFERENCE WHEN THE DEVICES WERE LOCKED AFTER ADJUSTMENT, LEADING TO SUSPICION THAT THERE MAY BE A MALFUNCTION IN THE DEVICES. AFTER ADJUSTMENT DURING THE DRY CHECK BEFORE INSERTION THERE WAS NO INTERFERENCE, BUT WHEN THE DEVICES WERE LOCKED, INTERFERENCE OCCURRED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES OF DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23280758 ↗
• MalfunctionJul 29, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE DEVICES WERE DENTED INWARD AT THE TIPS, MAKING THE HOLE SMALLER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22641950 ↗
• MalfunctionJul 29, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE DEVICES WERE DENTED INWARD AT THE TIPS, MAKING THE HOLE SMALLER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22641928 ↗
• MalfunctionJun 27, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRILLSLEEVE DIDN'T FIT IN THE PROTECTION SLEEVE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22346232 ↗
• MalfunctionJun 17, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT A BRAND NEW SLEEVE WAS BENT IN TRANSIT. IT WILL NOT SLIDE THROUGH THE OUTER PROTECTIONS SLEEVE AND POSES THE RISK OF GETTING STUCK IF FORCED. THE EVENT OCCURRED PREOPERATIVELY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22222272 ↗
• MalfunctionMay 30, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE DRILL GUIDE WAS BENT. THE SURGERY WAS DELAYED FOR 5 MIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22117632 ↗
• MalfunctionMar 18, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  DRILL SLEEVE IS BENT AND DOESN'T SEAT PROPERLY INTO PROTECTION SLEEVE. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21633935 ↗
• MalfunctionJan 31, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THERE WAS A PROBLEM WITH DRILLING A HOLE FOR THE LOCKING SCREW DUE TO PRESSURE ON THE AIMING ARM SYSTEM. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THE SURGEON STATED THEY REPEATEDLY CAME ACROSS THE NAIL WHILE DRILLING. THE DRILLING OF THE OBLIQUE LOCK WAS NOT A PROBLEM, THE PROBLEM WAS WITH THE CONNECTION BETWEEN THE TARGET BAR AND THE NAIL. IT COULD ONLY BE RELEASED FROM THE NAIL WITH EXTREME EXERTION AT THE END. IN THE SURGEON'S OPINION, IT WAS INITIALLY CORRECTLY MOUNTED, WHICH COULD HAVE CONTRIBUTED TO THE PROBLEM, THAT THEY LOWERED THE LEG FOR THE DISTAL, OBLIQUE LOCKING, THAT IS, THE KNEE STRETCHED AND THUS CERTAINLY BROUGHT TENSION TO THE CONNECTION NAIL/TARGET BRACKET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21283576 ↗
• MalfunctionJan 8, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR AN INTERTROCHANTERIC FRACTURE. THE SURGEON DRILLED THE MOST PROXIMAL HOLE AMONG THE DISTAL SCREW HOLES. THE DRILL BIT INTERFERED WITH THE HOLE. THE SURGEON CHECKED THE SIDES AND WAS ABLE TO INSERT THE DRILL BIT, SO THE SURGEON LEFT THE DRILL BIT IN PLACE. THE SURGEON DRILLED THE MOST DISTAL OBLIQUE LOCKING HOLE. THERE WAS NO INTERFERENCE BETWEEN A DRILL BIT AND THE OBLIQUE LOCKING HOLE, AND INSERTION OF A LOCKING SCREW WAS COMPLETED. THE SURGEON REMOVED THE DRILL BIT THAT WAS LEFT IN THE MOST PROXIMAL HOLE AMONG THE DISTAL SCREW HOLES AND INSERTED A LOCKING SCREW. THE SURGEON DRILLED THE DYNAMIC HOLE, WHICH IS THE HOLE IN THE MIDDLE. THE DRILL BIT INTERFERED WITH THE DYNAMIC HOLE. THE SURGEON DID NOT INSERT A LOCKING SCREW TO THE DYNAMIC HOLE AND COMPLETED THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN A THIRTY (30) MINUTE DELAY. PER THE SURGEON, IT WAS PRESUMED THAT THERE WAS RESISTANCE DURING NAIL INSERTION AND THAT THERE MAY NOT HAVE BEEN ENOUGH MEDULLARY REAMING; THERE WAS NO ALLEGATION AGAINST THE NAIL OR SCREWS. THE PATIENT OUTCOME WAS REPORTED AS STAB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21103199 ↗
• MalfunctionJan 8, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR AN INTERTROCHANTERIC FRACTURE. THE SURGEON DRILLED THE MOST PROXIMAL HOLE AMONG THE DISTAL SCREW HOLES. THE DRILL BIT INTERFERED WITH THE HOLE. THE SURGEON CHECKED THE SIDES AND WAS ABLE TO INSERT THE DRILL BIT, SO THE SURGEON LEFT THE DRILL BIT IN PLACE. THE SURGEON DRILLED THE MOST DISTAL OBLIQUE LOCKING HOLE. THERE WAS NO INTERFERENCE BETWEEN A DRILL BIT AND THE OBLIQUE LOCKING HOLE, AND INSERTION OF A LOCKING SCREW WAS COMPLETED. THE SURGEON REMOVED THE DRILL BIT THAT WAS LEFT IN THE MOST PROXIMAL HOLE AMONG THE DISTAL SCREW HOLES AND INSERTED A LOCKING SCREW. THE SURGEON DRILLED THE DYNAMIC HOLE, WHICH IS THE HOLE IN THE MIDDLE. THE DRILL BIT INTERFERED WITH THE DYNAMIC HOLE. THE SURGEON DID NOT INSERT A LOCKING SCREW TO THE DYNAMIC HOLE AND COMPLETED THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN A THIRTY (30) MINUTE DELAY. PER THE SURGEON, IT WAS PRESUMED THAT THERE WAS RESISTANCE DURING NAIL INSERTION AND THAT THERE MAY NOT HAVE BEEN ENOUGH MEDULLARY REAMING; THERE WAS NO ALLEGATION AGAINST THE NAIL OR SCREWS. THE PATIENT OUTCOME WAS REPORTED AS STAB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21103186 ↗
• MalfunctionSep 9, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PRODUCT HAS DAMAGE TO THE METAL IN THE INNER PORTION OF THE TROCAR. IT IS UNKNOWN WHEN THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20169581 ↗
• MalfunctionFeb 5, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE DRILL BIT INTERFERES WITH THE INSIDE OF THE DRILL SLEEVES. THERE ARE NO PIECES IN THE PATIENT. THE SURGEON CONFIRMED BY X-RAY. PATIENT IS STABLE. THIS REPORT IS FOR ONE DRILL SLEEVE / 4.2MM FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18644044 ↗
• MalfunctionFeb 5, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE DRILL BIT INTERFERES WITH THE INSIDE OF THE DRILL SLEEVES. THERE ARE NO PIECES IN THE PATIENT. THE SURGEON CONFIRMED BY X-RAY. PATIENT IS STABLE. THIS REPORT IS FOR ONE DRILL SLEEVE / Ø 4.2MM FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18642535 ↗
• MalfunctionJan 19, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SALES CONSULTANT WAS SHIPPED A DRILL GUIDE THAT WAS BENT AND WOULD NOT FIT INTO ITS COUNTERPART PROTECTION SLEEVE. THIS WAS FOUND DURING PREPARATION FOR STERILIZATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE DRILL SLEEVE / Ø 4.2MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18545337 ↗
• MalfunctionJan 19, 2024Device-Device Incompatibility; Device-Device Incompatibility

  THERE WAS NO SURGICAL DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED. THE PATIENT STATUS IS REPORTABLE AS STABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18542724 ↗
• MalfunctionJan 17, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN COLUMBIA AS FOLLOWS: IT WAS REPORTED THAT THE 11/8 SLEEVE PROTECTION GETS STUCK IN SURGERY WITH DRILL SL 4.2 AND STREAM 2.5 L950 DRILL GUIDE AND BENDS IN SURGERY. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) DRILLSL Ø4.2 THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18529224 ↗
• MalfunctionJun 5, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023 WHERE A RFNA WAS INSERTED, WAS MALLETING IN WITH SLEEVE IN JIG. SLEEVES WERE NOT ABLE TO BE DRILLED THROUGH BECAUSE IT HIT NAIL AND THEY WERE STUCK. UNABLE TO TAKEN OUT - MALLET ALSO WAS CHIPPED IN PROCESS. NAIL WAS NOT BILLED. THERE WAS NO SURGICAL DELAY. THERE WERE NO PATIENT OUTCOME OR CONSEQUENCES. THIS REPORT IS FOR ONE (1)DRILL SLEEVE / 4.2MM. THIS IS REPORT 7 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17059843 ↗
• MalfunctionJun 5, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023 WHERE A RFNA WAS INSERTED, WAS MALLETING IN WITH SLEEVE IN JIG. SLEEVES WERE NOT ABLE TO BE DRILLED THROUGH BECAUSE IT HIT NAIL AND THEY WERE STUCK. UNABLE TO TAKEN OUT - MALLET ALSO WAS CHIPPED IN PROCESS. NAIL WAS NOT BILLED. THERE WAS NO SURGICAL DELAY. THERE WERE NO PATIENT OUTCOME OR CONSEQUENCES. THIS REPORT IS FOR ONE (1)DRILL SLEEVE / 4.2MM. THIS IS REPORT 3 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17059813 ↗
• MalfunctionMay 8, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THERE WERE ISSUES WITH PROXIMAL LOCKING THE JIG WAS CHECKED WITH THE SLEEVE AND THE DRILL SLEEVE IN QUESTION IS SUSPECTED TO HAVE WORN EARLY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A DRILL SLEEVE / Ø 4.2MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16885848 ↗
• MalfunctionMay 1, 2023Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT APRIL 20, 2023, PRE OPERATIVELY, THE CUSTOMER REPORTS THAT A SLEEVE WAS BENT. THERE WAS A SURGICAL DELAY OF APPROXIMATELY 20 MINUTES. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) DRILL SLEEVE / Ø 4.2MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16843060 ↗
• MalfunctionMar 10, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, WHEN DRILLING FOR SCREW PLACEMENT IN THE PROXIMAL END OF THE ANS TIBIA NAIL, THE MOST DISTAL SCREW (IN THE PROXIMAL SECTION) THE DRILL BIT HIT THE NAIL AND DIDN¿T PASS THROUGH THE NAIL. IN ADDITION, THE TNA AIMING ARM DOES NOT APPEAR TO LINE UP WITH THE NAIL PROPERLY. WHEN DRILLING THE PROXIMAL STATIC MEDIAL TO LATERAL SCREW, THE 4.2 DRILL BIT WAS HITTING THE NAIL INSTEAD OF THE HOLE IN THE NAIL. THERE WAS A MILD DELAY IN SURGERY. THE SURGEON DECIDED TO NOT USE THE HOLE THAT THE DRILL BIT WAS MISSING AND MOVED ON TO ANOTHER HOLE IN THE NAIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, NO FRAGMENTS WERE GENERATED. IT WAS UNKNOWN IF THERE WAS ANY PATIENT OUTCOME/CONSEQUENCES. THIS REPORT IS FOR ONE (1) DRILL SLEEVE / Ø 4.2MM. THIS IS REPORT 7 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16521316 ↗