NA 03.010.200Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982068033), received between Nov 13, 2017 and Jan 30, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE PRODUCTS IN QUESTION. IN THE SURGERY, AFTER NAIL DETERMINATION, THE SURE-LOCK IN QUESTION WAS CALIBRATED, AND AFTER ADJUSTMENT WAS COMPLETED, THE SURE-LOCK WAS REMOVED AND THE PROXIMAL TFNA PROCEDURE WAS PERFORMED. AFTER COMPLETING THE PROXIMAL PROCEDURE, THE SURGEON MOVED ON TO THE DISTAL PROCEDURE. AFTER GUIDING THE SURGEON THROUGH THE EXACT PROCEDURE AND CONFIRMING THE SURE-LOCK WITH AN IMAGE, THE ML REGULAR CIRCLE HOLE WAS DRILLED, BUT IT INTERFERED. THE INTERFERED HOLE WAS PUT OFF AND THE SURGEON REPLACED WITH A DRILL IN THE SURE-LOCK INSTRUMENT INSTEAD OF THE DRILL IN QUESTION WHICH WAS ENTRUSTED TO THE HOSPITAL. AFTER INSERTING THE DISTAL ELLIPTICAL HOLE FIRST, HE AGAIN DRILLED THE REGULAR CIRCULAR HOLE WITH FINE ADJUSTMENTS AT HAND, AND SCREW INSERTION WAS COMPLETED AS PLANNED WITHOUT ANY PROBLEMS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE PRIMARY SURGEON SUGGESTED THAT THE CAUSE OF THE INTERFERENCE MAY HAVE BEEN THE BENDING AND FLEXURE OF THE SURE-LOCK BODY DUE TO THE STRESS CAUSED BY MOVING THE BODY IN AN ATTEMPT TO SPEED UP THE PROCEDURE, AND THE DRILL TIP, WHICH HAD BEEN USED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21276206 ↗
• MalfunctionDec 3, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN UNKNOWN SURGERY VIA TFNA LONG WITH THE PRODUCT IN QUESTION. BEFORE THE SURGERY, WHILE SETTING UP THE CONSIGNMENT INSTRUMENT, IT WAS FOUND THAT THE NUT FOR THE PART THAT ADJUSTS THE LENGTH OF THE INSTRUMENT IN QUESTION WAS MISSING. THE SURGERY WAS PROCEEDED BY FREE HANDED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. PATIENT OUTCOME IS REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20835357 ↗
• MalfunctionMar 19, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS FURTHER REPORTED THE SURGERY WAS COMPLETED USING AN ALTERNATIVE PRODUCT. PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18933581 ↗
• MalfunctionFeb 8, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024 THE PATIENT UNDERWENT AN UNKNOWN NAILING SURGERY. AN ADJUSTABLE DEVICE WAS SET FOLLOWING LENGTH OF NAIL, AND THEN A NUT WAS TEMPORARILY TIGHTENED BY HAND AND A WRENCH. A CALIBRATION SCREW WAS USED AND ADJUSTED FOR CORRECT ANGLE TOWARD ML DIRECTION. WHEN CHECKING WITH THE CALIBRATION PIN WAS ATTEMPTED, ADJUSTING SEEMED LIKE PROPER CONDITION AND THE PIN WAS INSERTED CORRECTLY. A NUT WAS RETORQUED, AFTER THAT, CHECKING WITH THE CALIBRATION PIN WAS MISSED. AFTER THE NAIL WAS INSERTED, THE SCREWDRIVER INTERFERED WITH THE NAIL WHEN DISTAL LOCKING SCREW WAS BEING INSERTED. WHEN CHECKING WITH AN IMAGE INTENSIFIER, PROPER ADJUSTING WAS CONFIRMED FROM LATERAL SIDE. ON THE OTHER HAND, AN ACTUAL DRILL BIT WAS MISALIGNED FROM A HOLE IN CASE OF FRONT SIDE VIEW. THEREFORE, NUT FOR SURELOCK WAS LOOSE AND READJUSTING FOR LENGTH WAS MADE ON FRONT SIDE. THEREBY, ADJUSTING WAS SUCCESSFUL FOR BOTH FRONT AND LATERAL SIDES. A GUIDE PINF2.8¿ WAS USED AND PRE HOLE IN SCREW ONE WAS MADE, THE DRILL PASSED THROUGH SCREW HOLE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH ADDITIONAL 45 MINUTES. THE SURGEON COMMEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18669588 ↗
• MalfunctionOct 22, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE SURGERY WITH THE TFNA LONG NAIL. DURING THE SURGERY, WHEN THE SURGEON TRIED TO INSERT THE DISTAL STOP BY USING THE SURELOCK IN QUESTION, THE DRILL INTERFERED WITH BOTH HOLES OF THE NAIL, SO THE REAMING ENDED UP WITH 1.5 MM OVERREAMING. AFTER INSERTING THE NAIL, THE SURGEON ADJUSTED THE FRONT AND BACK OF THE SURELOCK BY USING THE IMAGE. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICES REPORTED: UNKNOWN TFNA - NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). UNKNOWN GUIDES/SLEEVES/AIMING: SLEEVE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) SURELOCK AIMING ARM FOR ANTEGRADE FEMORAL NAILS. THIS REPORT IS 1 OF 1 OF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12680919 ↗
• MalfunctionOct 7, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT UNDERWENT SURGERY FOR FEMORAL TROCHANTERIC FRACTURES. BEFORE THE NAIL INSERTION, THE SLEEVE (MANUFACTURED BY ARIOMEDICAL) INTERFERED WITH THE SURELOCK AIMING ARM AND IT COULDN¿T BE CONNECTED TO THE AIMING ARM PROPERLY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A 30 MINUTE DELAY. THIS REPORT IS FOR ONE (1) SURELOCK AIMING ARM FOR ANTEGRADE FEMORAL NAILS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10643711 ↗
• MalfunctionFeb 28, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, SURGERY FOR FEMORAL DIAPHYSEAL FRACTURE WAS PERFORMED USING THE SURELOCK DISTAL TARGETING DEVICE. INTRAOPERATIVELY, TWO EVENTS WERE CONFIRMED BY THE SURGEON. THE DRILL BIT HIT THE NAIL. THE INSERTION OF LOCKING SCREW 5.0 MM/34MM WAS SUCCESSFUL AT THE SECOND HOLE FROM THE DISTAL END. HOWEVER, THE DRILL BIT HIT THE NAIL WHEN DRILLING AT THE MOST DISTAL OVAL HOLE. A LOCKING SCREW 5.0MM/36MM WAS INSERTED AT THE OVAL HOLE. SECONDARILY, THE SURGEON CONFIRMED UNDER THE IMAGE THAT THIS LOCKING SCREW 5.0MM/36MM, WHICH WAS INSERTED AT THE OVAL HOLE, WAS BEING OUT OF BOUNDS (NOT INSERTED TO THE SCREW HOLE). HE COULD NOT REMOVE THIS SCREW, SO HE LEFT THE SCREW IN THE BONE. THEN, BY USING RADIOLUCENT DRIVE, HE DRILLED AT THE OVAL HOLE AND INSERTED A LOCKING SCREW AT THE DISTAL FAR END. THE SURGERY WAS COMPLETED WITH A 20-MINUTE DELAY, AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICES: DRILL BIT (PART# 03.010.061, LOT# UNKNOWN, QTY 1); SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QTY UNKNOWN); LOCKING SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QTY UNKNOWN); FEMORAL NAIL (PART# U

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7302820 ↗
• MalfunctionNov 13, 2017Failure to Align; Failure to Align

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE REPORTED DEVICE WAS USED IN THE SURGERY FOR THE FEMORAL TROCHANTERIC FRACTURE ON (B)(6) 2017. THE TFNA NAIL (LONG) WAS USED FOR THE PROCEDURE. WHEN THE SURGEON TRIED TO DRILL THE HOLE FOR THE DISTAL LOCKING SCREW BY USING THE SURELOCK AIMING ARM FOR ANTEGRADE FEMORAL NAILS, THE DRILL BIT INTERFERED WITH THE NAIL. IT WAS FOUND THAT THE CONNECTING PART OF THE SURELOCK AIMING ARM TO THE HANDLE HAD BEEN LOOSE. ONE OF THE THREE PROJECTED PARTS ON THE AIMING ARM, WHICH WERE ALL SUPPOSED TO BE FIXED USUALLY, HAD NOT BEEN FIXED (IT WAS RECESSED). THE SURGERY WAS EXTENDED FOR SIXTY (60) MINUTES. NO ADVERSE CONSEQUENCE TO THE PATIENT WAS REPORTED, PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE: TFNA NAIL LONG (QUANTITY 1), DRILL BIT (QUANTITY 1). THIS REPORT IS FOR ONE (1) SURELOCK AIMING ARM FOR ANTEGRADE FEMORAL NAILS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7025620 ↗