NA 03.168.014Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 10886982274489), received between Nov 2, 2018 and Sep 15, 2026 — classified as 2 injuries, 52 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (27 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Insufficient Device Problem Information

  It was reported that sales rep found the item in decontamination area. There was no product allegation reported. There was no patient involvement.During manufacturer's investigation of the returned device it was identified that the tip of the T25 SDDRIVE SCREWDRIVER SHAFT 241MM was worn/stripped and twisted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50775104 ↗
• MalfunctionSep 11, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50735002 ↗
• MalfunctionJun 18, 2026Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THERE WAS A BROKEN SCREWDRIVER. A SCREW WAS REMOVED AND STUCK ON THE TIP AND WHEN IT CAME OUT OF DECONTAMINATION A PLIER WAS USED TO TRY AND REMOVE THE SCREW, AND THE TIP BROKE OFF. IT DID NOT HAPPEN DURING A SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25546564 ↗
• MalfunctionApr 2, 2026Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE PRODUCT IN QUESTION. IN THE SURGERY, THE SCREWDRIVER HAD WORN DOWN DURING USE, PREVENTING IT FROM GRIPPING THE SCREW AND CAUSING IT TO SPIN FREELY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24769763 ↗
• MalfunctionMar 6, 2026Material Twisted/Bent

  IT WAS REPORTED THAT RETENT PIN SCRDRIVER QC HEX 12/SHT/XL25, T15 CANN STRDRV SCRWDRVR SFT SLF-RETAIN, 2.7MM CANN DRILL BIT QC/145MM, SCRDRIVER-HEX-SMALL W/HOLD-SLEEVE, MONOBLOC FLEXIBLE REAMER 14 - STD - DD, MONOBLOC FLEX REAMER 14.5 - LONG - DD, DRIVE SHAFT FOR RIA 2 520MM, T25 SDDRIVE SCREWDRIVER SHAFT 241MM, AND TORQUE LIMITING ATTACHMENT 4NM FOR AO REAMING COUPLER WERE REPORTED AS DAMAGED DURING POST-OPERATIVE INSPECTION. THE FAILURES INCLUDED BROKEN TIPS, STRIPPED FEATURES, RUST INSIDE CANNULAS, AND NON-FUNCTIONING TORQUE LIMITER. THERE WAS NO PATIENT INVOLVEMENT OR HARM, AND NO PROCEDURE WAS ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24533375 ↗
• MalfunctionMar 5, 2026Material Twisted/Bent

  IT WAS REPORTED WHILE INSPECTING THE SCREWDRIVER SHAFT IT WAS NOTICED IT WAS DAMAGED. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24520079 ↗
• MalfunctionDec 23, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT, THE SCREWDRIVER SHAFT WOULD NOT CONNECT TO THE TORQUE, LIMITING ATTACHMENT. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23877878 ↗
• 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 22574868 ↗
• 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 22567001 ↗
• MalfunctionMay 23, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT WHILE INSPECTING THE POWER SCREWDRIVER IN THE FNS SET IT WAS NOTICED THAT THE END OF THE POWER SCREWDRIVER WAS TWISTED. THE EVENT DID NOT OCCUR DURING STERILE PROCESSING, NOR DURING FIELD INSPECTION NOR DURING CALIBRATION. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22078618 ↗
• MalfunctionApr 22, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE DRIVER TIP STRIPPED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21881335 ↗
• MalfunctionApr 4, 2025Break; Calibration Problem; Material Twisted/Bent; Break; Calibration Problem; Material Twisted/Bent

  IT WAS REPORTED ON MAR 11, 2025, THAT THE TIP IS TORQUED, TWISTED, AND CHIPPED. NO OPERATION WAS INVOLVED. THERE WERE NO PATIENT CONSEQUENCES AND NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21773332 ↗
• MalfunctionMar 5, 2025Device-Device Incompatibility; Material Deformation; Material Twisted/Bent; Device-Device Incompatibility; Material Deformation; Material Twisted/Bent

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE SCREWDRIVER HEADS WERE WARPED. THE TIP OF THE SCREW DRIVERS WAS TWISTED AND WON'T ATTACH TO A SCREW. THEY DIDN'T BREAK, BUT THEY WON'T WORK. BOTH SCREW DRIVERS FROM THE TRAY HAD TIPS THAT WERE WARPED BUT NOT BROKEN AT THE SHAFT OR ANYTHING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21529889 ↗
• MalfunctionMar 5, 2025Device-Device Incompatibility; Material Deformation; Material Twisted/Bent; Device-Device Incompatibility; Material Deformation; Material Twisted/Bent

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE SCREWDRIVER HEADS WERE WARPED. THE TIP OF THE SCREW DRIVERS WAS TWISTED AND WON'T ATTACH TO A SCREW. THEY DIDN'T BREAK, BUT THEY WON'T WORK. BOTH SCREW DRIVERS FROM THE TRAY HAD TIPS THAT WERE WARPED BUT NOT BROKEN AT THE SHAFT OR ANYTHING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21529871 ↗
• MalfunctionSep 11, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE PATIENT STATUS/OUTCOME WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20189163 ↗
• MalfunctionAug 22, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE TIP OF THE SCREWDRIVER BROKE OFF IN THE SCREW HEAD INTRAOPERATIVELY. SURGEON HAD TO USE A BURR TO CUT OUT THE SCREW. THERE WAS A THIRTY (30) MINUTES OF SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) T25 STARDRIVE SCREWDRIVER SHAFT 241MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 20040616 ↗
• MalfunctionMar 8, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT A SURGERY TO REMOVE AN FNS (FEMORAL NECK SYSTEM) BECAUSE THEY WERE GETTING A TOTAL HIP REPLACEMENT. DURING THE FNS REMOVAL SURGERY, THE HEAD OF THE DRIVER COMPLETELY BENT AND BROKE. BECAUSE OF THIS, THEY HAD TO CUT THE BOTTOM OF THE PLATE FROM THE BOLT AND USE PLIERS TO REMOVE THE STRIPPED SCREW AND REMAINING PLATE FROM THE PATIENT. THE SCREW WAS COLD WELDED TO THE PLATE. THE HARDWARE WAS SUCCESSFULLY REMOVED. THE SURGERY WAS DELAYED BY APPROXIMATELY 20 MINUTES DUE TO THE EVENT. THIS REPORT INVOLVES ONE T25 STARDRIVE SCREWDRIVER SHAFT 241MM. THIS COMPLAINT IS RELATED TO (B)(4). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18864285 ↗
• MalfunctionFeb 5, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRIVER TIP BROKE IN SURGERY. THERE WERE NO SURGICAL DELAY AND NO PATIENT CONSEQUENCES/OUTCOME. THIS REPORT IS FOR ONE (1) T25 SDDRIVE SCREWDRIVER SHAFT 241MM THIS IS REPORT 1 OF 1 FOR COMPLAINT(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18647062 ↗
• MalfunctionJan 11, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED, THAT ON AN UNKNOWN DATE. THE T25 SCREWDRIVER¿S THREADS WERE WORN DOWN AND NO LONGER USABLE. GIVING DIFFICULTY IN TIGHTENING THE SCREWS DOWN, AS THE HEAD OF THE SCREWDRIVER WAS PINNED IN THE RECESS OF THE SCREW. NO PATIENT WAS INVOLVED. THIS REPORT INVOLVES ONE T25 STARDRIVE SCREWDRIVER SHAFT 241MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18490901 ↗
• MalfunctionJan 11, 2024Material Twisted/Bent; Material Twisted/Bent

  INDIRECTLY, THERE WAS PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 18490896 ↗
• MalfunctionDec 1, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON NOVEMBER 9, 2023, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE FNS FOR FEMORAL NECK FRACTURE. WHEN THE TORQUE LIMITER AND THE SCREWDRIVER SHAFT WERE ASSEMBLED, THEY WERE STIFF AND DIFFICULT TO ASSEMBLE. ALTHOUGH THE SURGEON MANAGED TO ASSEMBLE THEM, THE TORQUE LIMITER DID NOT WORK DURING SCREW INSERTION. ADDITIONALLY, IT WAS DIFFICULT TO REMOVE THE SCREWDRIVER SHAFT. IT WAS FINALLY REMOVED WITH PLIERS AND A HAMMER. THE SURGEON GUESSED THAT TORQUE COULD NOT BE APPLIED DUE TO POOR CONNECTION WITH THE SCREWDRIVER SHAFT CAUSED BY INTERNAL DEFECTS IN THE TORQUE LIMITER IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE SURGEON COMMENTED THAT HE CANNOT USE THE DEVICE WITH THE DEFECT AND WOULD NOT USE FNS IN THE FUTURE. PATIENT STATUS/ OUTCOME: STABLE NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) SCRDRIVERSHAFT T25 L241. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18246213 ↗
• MalfunctionNov 2, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, THE DEVICES IN QUESTION BROKE. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A T25 STARDRIVE SCREWDRIVER SHAFT 241MM. THIS IS REPORT 5 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18058913 ↗
• MalfunctionNov 2, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, THE DEVICES IN QUESTION BROKE. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A T25 STARDRIVE SCREWDRIVER SHAFT 241MM. THIS IS REPORT 1 OF 8 FOR PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18058884 ↗
• MalfunctionOct 19, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED ON OCTOBER 3, 2023, THAT THE SHAFT SCREWDRIVER WAS REPORTED AS NOT ABLE TO GAIN PURCHASE AROUND SCREW HEAD. INSPECTION REVEALED WEAR AND TEAR AROUND END OF SCREWDRIVER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. PATIENT STATUS/ OUTCOME: NO PATIENT IMPACT. THIS REPORT IS FOR ONE (1) T25 SDDRIVE SCREWDRIVER SHAFT 241MM THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17967626 ↗
• MalfunctionOct 19, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED ON (B)(6) 2023, THAT THE SHAFT SCREWDRIVER WAS REPORTED AS NOT ABLE TO GAIN PURCHASE AROUND SCREW HEAD. INSPECTION REVEALED WEAR AND TEAR AROUND END OF SCREWDRIVER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. PATIENT STATUS/ OUTCOME: NO PATIENT IMPACT. THIS REPORT IS FOR ONE (1) T25 SDDRIVE SCREWDRIVER SHAFT 241MM. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17967621 ↗