NA 03.010.516Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982069290), received between Feb 1, 2019 and Jul 23, 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.

• MalfunctionJul 23, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON UNKNOWN DATE THE TRILEAP MPJ PLATE WAS USED AND SCREW DID NOT LOCK IN, UNSURE IF IT WAS BECAUSE USED A CONICAL EXTRACTOR TO REMOVE SCREW. 2.0 PLATE ALSO DID NOT LOCK IN. RUST ON GRAPHIC CASES AND INSTRUMENTS TO BE REPLACED. THERE WAS NO PATIENT CONSEQUENCES. (B)(4) ARE RELATED TO EACH OTHER. (B)(4) IS CREATED TO CAPTURE THE ADDITIONAL IPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22574929 ↗
• MalfunctionJul 22, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON UNKNOWN DATE THE TRILEAP MPJ PLATE WAS USED AND SCREW DID NOT LOCK IN, UNSURE IF IT WAS BECAUSE USED A CONICAL EXTRACTOR TO REMOVE SCREW. 2.0 PLATE ALSO DID NOT LOCK IN. RUST ON GRAPHIC CASES AND INSTRUMENTS TO BE REPLACED. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22567065 ↗
• MalfunctionApr 24, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, A QUICK COUPLING WAS BROKEN ON A DEVICE. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21903775 ↗
• MalfunctionJul 8, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSTRUMENTS WERE BROKEN. IT IS UNKNOWN IF THERE WAS PATIENT OR PROCEDURE INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE HANDLE/ LARGE WITH QUICK COUPLING. THIS IS REPORT 7 OF 8 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS ARE CAPTURED IN (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19694394 ↗
• MalfunctionApr 6, 2022Fitting Problem; Fitting Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY WITH THE FEMORAL NECK SYSTEM (FNS) IMPLANTS. AFTER THE SURGERY, REVISION SURGERY WAS COMPLETED ON (B)(6) 2022, DUE TO THE BONE UNION FAILURE, FEMORAL NECK SHORTENING AND PAIN. IN THIS REVISION SURGERY, THE SURGEON HAD DIFFICULTY REMOVING THE FNS IMPLANTS. A HANDLE/LARGE WITH QUICK COUPLING AND AT25 STARDRIVE¿ SCREWDRIVER SHAFT WAS USED TO REMOVE THE FNS IMPLANTS, BUT THE IMPLANTS COULD NOT BE REMOVED DUE TO THE DISTAL SCREW BEING FIXED FIRMLY. ANOTHER COMPANY¿S SCREWDRIVER WAS USED FOR THE REMOVAL, AND THE SCREWDRIVER TIP BECAME STRIPPED. IT WAS SUGGESTED TO USE THE INSERTION HANDLE WITH FORCE AND ATTEMPT REMOVAL, BUT THE SURGEON CHOSE TO USE A CARBIDE DRILL. THE PLATE CAME OFF, BUT THE TIP OF SCREW REMAINED IN THE BONE. ANOTHER COMPANY'S INSTRUMENT WAS USED, AND RESIDUAL FRAGMENTS COULD BE REMOVED. THE REMOVAL OF IMPLANT FOR DELAYED UNION OF FEMORAL NECK FRACTURE AND ARTIFICIAL HEAD REPLACEMENT WERE COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS (B)(4) IS LINKED TO (B)(4) WHICH REPORTS ABOUT THE BONE U

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14028054 ↗
• MalfunctionJan 24, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT GOT THE RIGHT FEMORAL NECK FRACTURE (GARDEN) BY AN UNKNOWN REASON. ON THE SAME DAY, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION SURGERY WITH A FEMORAL NECK SYSTEM (FNS). PATIENT MADE GOOD PROGRESS AFTER THE OPERATION. HOWEVER, THE PATIENT FELL ON (B)(6) 2020 AND GOT RIGHT FEMORAL SUBTROCHANTERIC FRACTURE AND LEFT PROXIMAL HUMERAL FRACTURE. ON THE SAME DAY, THE PATIENT UNDERWENT REOPERATION AND THE FNS WAS REPLACED BY TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) WITH THE PURPOSE OF FIXING THE SUBTROCHANTERIC FRACTURE. THERE WAS NO DISPOSITION IN THE FEMORAL NECK FRACTURE. DURING THE REOPERATION, THE SURGEON HAD DIFFICULTY IN REMOVING THE LOCKING SCREW WITH A SCREWDRIVER SHAFT AND A HANDLE BECAUSE THE TORQUE WAS INSUFFICIENT. HE USED ANOTHER SCREWDRIVER SHAFT INSTEAD AND REMOVED THE SCREW SUCCESSFULLY. THERE WAS NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT CAPTURES THE INTRAOPERATIVE DIFFICULTY IN REMOVAL OF IMPLANTS USING A SCREWDRIVER SHAFT AND A HANDLE, WHILE RELATED COMPLAINT (B)(4) CAPTURES THE REVISION SURGERY PERFORMED ON (B)(6)

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9627166 ↗
• MalfunctionApr 18, 2019Device-Device Incompatibility; Device-Device Incompatibility

  UNKNOWN HAMMER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8527332 ↗
• MalfunctionFeb 1, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, DURING THE REMOVAL SURGERY FOR THE FEMORAL NECK SYSTEM (FNS), THE SURGEON HAD DIFFICULTY IN REMOVING THE LOCKING SCREW IN QUESTION TOGETHER WITH THE HANDLE LARGE WITH QUICK COUPLING. ORIGINALLY, THE PATIENT UNDERWENT A SURGERY FOR THE MEDIAL PROXIMAL FEMORAL NECK FRACTURE WITH FEMORAL NECK SYSTEM ON AN UNKNOWN DATE. THE SURGEON COMMENTED THAT DURING THE REMOVAL, RELATIVELY LARGE TORQUE IS NEEDED TO UNTIGHTEN THE LOCKING SCREW OF THE FNS. THE SURGEON WANTS THE DESIGN OF THE HANDLE WITH QUICK COUPLING CHANGED TO THE T TYPE WRENCH SHAPE. THE SURGEON COULD ONLY EXTRACT THE SCREW BY USING THE LOWMAN BONE HOLDING CLAMP ATTACHED TO A DRIVER. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FIVE (5) MINUTE SURGICAL DELAY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT IS FOR ONE (1) HANDLE/LARGE WITH QUICK COUPLING.. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8298136 ↗