NA 03.010.518Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10886982069313), received between Sep 21, 2018 and May 21, 2026 — classified as 34 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (13 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2026Break; Material Deformation

  IT WAS REPORTED THAT THERE WERE MULTIPLE ITEMS THAT WERE WARPED OR BROKEN AT THE FACILITY. THERE WAS NO HARM TO THE PATIENT AND NO DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25240867 ↗
• MalfunctionFeb 12, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT AN ORIF FOR TROCHANTERIC FRACTURE WITH THE SCREW AND THE SCREWDRIVER. DURING THE TFNA LONG OPERATION, AFTER COMPLETING INSERTION OF THE SECOND DISTAL INTERLOCKING SCREW, THE SURGEON TRIED TO REMOVE THE SCREWDRIVER, BUT IT HAD BECOME STUCK TO THE SCREW AND COULD NOT BE PULLED OUT. WHEN THE SURGEON TRIED PULL IT OUT WITH FORCE, IT BECAME STUCK TO THE SCREW AND CAME OUT TOGETHER. THIS SCREW WAS NOT USED, AND A DIFFERENT SCREW WAS INSERTED INTO THE DISTAL OBLIQUE HOLE VIA A DIFFERENT HOLE, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24321532 ↗
• MalfunctionNov 17, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT OSTEOSYNTHESIS SURGERY FOR TROCHANTERIC FEMORAL FRACTURE WITH THE LOCKING SCREW. THE SURGEON USED THE LOCKING SCREW FOR THE SURGERY VIA TFNA, HOWEVER DUE TO A POOR FIT AND WOBBLY DRIVER WITH THE LOCKING SCREW, THE LOCKING SCREW DID NOT ENTER THE HOLE AFTER PRE-DRILLING AND SLID THROUGH THE BONE, CAUSING THE ABERRANT LOCKING SCREW TO ENTER THE BODY. THE INCISION WAS ENLARGED, AND THE ERRANT PARTS WERE REMOVED. ANOTHER PRODUCT WAS USED INSTEAD, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23572972 ↗
• MalfunctionAug 7, 2025Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT ORIF SURGERY WITH THE SCREWDRIVER SHAFT. TFNA WAS USED FOR THIS CASE. THE SURGEON TRIED TO INSERT AN XL25 STANDARD LOCKING SCREW USING THE SCREWDRIVER SHAFT FOR DISTAL INTERLOCKING, BUT THE SCREW HEAD WAS NOT STABLE DUE TO A LOOSE FIT BETWEEN THE SCREWDRIVER SHAFT AND THE SCREW HEAD, AND THE SCREW FELL OFF AND WENT OUTSIDE THE BONE. THE NURSE ALSO POINTED OUT TO THE SALES REP WHEN ATTACHING THE SCREW AND SCREWDRIVER, AND THIS WAS A CASE IN WHICH MANIPULATION WITHIN THE WOUND WAS ALSO HINDERED. 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 22742337 ↗
• MalfunctionJun 26, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT ORIF SURGERY FOR TROCHANTERIC FEMORAL FRACTURE WITH THE SCREWDRIVER. THE TFNA LONG WAS USED FOR TROCHANTERIC FEMORAL FRACTURE. WHEN USING LOCKSCR F/NAILS Ø5 L 40 XL25 FOR DISTAL LOCKING, THE SCREW HAD A LARGE AMOUNT OF PLAY WITH THE SCREWDRIVER AND WAS DEEMED INCOMPATIBLE. ALTHOUGH THERE WAS NO PROBLEM WITH INSERTING THE SCREW ITSELF, THERE WAS A RATTLING SENSATION WHEN TURNING IT. IN PARTICULAR, IN THE DISTAL AREA, WHERE THE MEDULLARY CAVITY IS WIDE, THE DISTANCE TO THE NAIL INCREASES, AND IT WAS POINTED OUT THAT IF THE PLAY BETWEEN THE DRIVER AND THE SCREW BECOMES LARGE, THE RISK OF OB INCREASES. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. PATIENT OUTCOME IS REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338362 ↗
• MalfunctionMay 5, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT THE ORIF SURGERY FOR FEMORAL SHAFT TUMOR WITH THE SCREWDRIVER AND THE LOCKING SCREW. AT THE TIME INSERTING THE DISTAL LOCKING SCREW AFTER USING SURELOCK FOR TFNA LONG NAIL, THE SURGEON ATTACHED THE ANS LOCKING SCREW (5.0MM) USING THE SCREWDRIVER (T25). HOWEVER, THERE WAS A GAP BETWEEN TIP OF THE SCREWDRIVER AND THE SCREWHEAD, AND NO GRIPPING FORCE AT ALL. THE INSERTION WAS COMPLETED WITH NO PROBLEM, BUT IT MIGHT CAUSE STRIPPING THE SCREWHEAD. THE SALES REP FELT THAT TIP OF THE SCREWDRIVER WAS ONE ROUND SMALLER THAN THE SCREWHEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21963094 ↗
• MalfunctionOct 24, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THERE WAS WEAR AND TEAR ON THE INSTRUMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20523919 ↗
• MalfunctionSep 6, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024 THE T25 LONG DRIVERS WERE USED AND STRIPPED THEN DISCARDED BY THE STAFF. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20162050 ↗
• MalfunctionSep 6, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024 THE T25 LONG DRIVERS WERE USED AND STRIPPED THEN DISCARDED BY THE STAFF. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20161775 ↗
• MalfunctionSep 6, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024 THE T25 LONG DRIVERS WERE USED AND STRIPPED THEN DISCARDED BY THE STAFF. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20161567 ↗
• MalfunctionMay 3, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE SURGEON WAS TRYING TO REMOVE A 5 MM LOCKING SCREW FROM A FNS SIDE PLATE AND THE SCREWDRIVER END WAS TWISTED. THE SURGEON COULD NOT USE THE SCREWDRIVER TO REMOVE THE SCREW, HAD TO USE A CARBIDE DRILL BIT TO REMOVE SCREW HEAD, THEN A TREPHINE AND CONICAL EXTRACTOR TO REMOVE THE SCREW. THERE WAS NO SURGERY DELAYED DUE TO THE REPORTED EVENT. SURGEON UTILIZED OTHER INSTRUMENTS TO REMOVE THE SCREW. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO FRAGMENTS GENERATED. THIS REPORT IS FOR ONE (1) SD SCREWDRIVER/T25 SELF RETAINING/319. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19238815 ↗
• MalfunctionFeb 28, 2024Break; Crack; Break; Crack

  IT WAS REPORTED ON UNKNOWN EVENT DATE THAT REPORTER WAS UNABLE TO STERILIZE/ASSEMBLE. CHIPPING AND CRACKING.. UNABLE TO USE. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY AND PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1)SD SCREWDRIVER/T25 SELF RETAINING/319 THIS IS REPORT 2 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18800746 ↗
• MalfunctionJun 5, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, A TREPHINE FROM THE BROKEN SCREWS WAS DAMAGED. THE TWO TFNA LOCKING SCREWDRIVERS, SINCE THE TFN LOCKING SCREW WAS SOLDERED TO THE PLATE. THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER/T25 SELF RETAINING/319MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17064989 ↗
• MalfunctionApr 13, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT DURING THE CLEANING PROCESS IT WAS DISCOVERED THAT SCREWDRIVERS ARE EXCESSIVELY WORN IN THE FRONT AREA. THERE WERE NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE SCRDRIVER T25 SELF-HOLDING L319. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16731225 ↗
• MalfunctionFeb 3, 2023Crack; Contamination /Decontamination Problem; Device-Device Incompatibility; Scratched Material; Crack; Contamination /Decontamination Problem; Device-Device Incompatibility; Scratched Material

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT THE DEVICES WERE UNABLE TO USE OR STERILIZE AND ASSEMBLE, BECAUSE THE OF CHIPPING AND CRACKING. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR ONE (1) SD SCREWDRIVER/T25 SELF RETAINING/3190. THIS IS REPORT 4 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16300432 ↗
• MalfunctionFeb 3, 2023Crack; Contamination /Decontamination Problem; Device-Device Incompatibility; Scratched Material; Crack; Contamination /Decontamination Problem; Device-Device Incompatibility; Scratched Material

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT THE DEVICES WERE UNABLE TO USE OR STERILIZE AND ASSEMBLE, BECAUSE THE OF CHIPPING AND CRACKING. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR ONE (1) SD SCREWDRIVER/T25 SELF RETAINING/3190. THIS IS REPORT 3 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16300331 ↗
• MalfunctionJan 31, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT THE SCREWDRIVER DOES NOT HOLD THE SCREWS, MAKES IT DIFFICULT TO IMPLANT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: TRAUMA (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) SCRDRIVER T25 SELF-HOLDING L319. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16271098 ↗
• MalfunctionOct 28, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THE AIMING INSTRUMENTS WERE NOT LINING UP AND THE SCREW DRIVER WAS NOT ADVANCING THE SCREW. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A STARDRIVE SCREWDRIVER/T25 SELF RETAINING/319MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15691198 ↗
• MalfunctionSep 7, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT SURGERY WITH TFNA IMPLANTS. DURING SURGERY, AFTER INSERTING THE FIRST LOCKING SCREW DISTALLY, THE BLOOD ATTACHED TO THE SCREWDRIVER WAS WIPED WITH GAUZE, AND A SMALL METAL FRAGMENT ADHERED TO THE GAUZE. THE DETAILS OF THE PROCEDURE WERE AS FOLLOWS. ONCE THE LOCKING SCREW WAS INSERTED, THE SURGEON CONFIRMED THE INSERTION STATUS BY THE IMAGE INTENSIFIER AND TAPPED THE SCREWDRIVER LIGHTLY WITH A HAMMER TO CONNECT IT TO THE LOCKING SCREW FOR FURTHER TIGHTENING OF THE LOCKING SCREW. THE SURGEON COMMENTED THAT IT WAS UNLIKELY THAT A DRILL BIT AND THE NAIL INTERFERED BECAUSE THE SURGEON DRILLED AT THE CENTER OF THE SCREW HOLE OF THE NAIL PRECISELY, ALTHOUGH DRILLING WAS PERFORMED MANUALLY. IN ADDITION, THE SURGEON COMMENTED THAT THE HEAD OF THE LOCKING SCREW HAD A DEBRIS LIKE MATERIAL ON IT. THE SURGEON CONFIRMED THAT THERE WERE NO METAL FRAGMENTS LEFT IN THE PATIENT¿S BODY BY THE IMAGE INTENSIFIER AND X-RAY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE STARDRIVE SCREWDRIVER/T25 SELF RETA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15369333 ↗
• MalfunctionAug 1, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ITEMS SEEM TO HAVE BEEN AFFECTED BY THE HIGH TEMPERATURES OF THE WASHING/STERILIZATION PROCESS. SOME OF THE PLASTICS MELTED AND THE RUBBERS ON SOME TOOLS ARE OILY AND STICKY. THERE IS NO REPORTED PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A STARDRIVE SCREWDRIVER/T25 SELF RETAINING/319MM. THIS IS REPORT 3 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15138057 ↗
• MalfunctionJun 28, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE STARDRIVE SHAFT TIP TWISTED AND TORQUED, AND IS UNABLE TO BE USED. THE HOSPITAL PROVIDED THE INSTRUMENTATION TO THE SALES REP WITHOUT ANY EXPLANATION ON EVENT OR CASE INFORMATION. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. PATIENT AND PROCEDURE INVOLVEMENT ARE UNKNOWN. THIS REPORT IS FOR A STARDRIVE SCREWDRIVER/T25 SELF RETAINING/319MM. THIS IS REPORT 2 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14842178 ↗
• MalfunctionJun 7, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: I¿M RAISING THIS COMPLIANT DUE TO AN ISSUE INCURRED WITH A SCREWDRIVER (03.010.518) DURING A CASE TODAY. THE SURGEON BELIEVES THE SCREWDRIVER HEAD HAD BEEN ROUNDED OFF CAUSING IT NOT TO GRIP THE SCREW HEAD FULLY. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: TRAUMA(PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES ONE(1) DEVICE SCREWDRIVER T25 SELF-HOLDING L319. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14620004 ↗
• MalfunctionJun 6, 2022Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT A SCREWDRIVER BROKE DURING A PROCEDURE PERFORMED ON (B)(6) 2022. THE SPRING INSIDE THE SCREWDRIVER BROKE HENCE WON¿T RELEASE THE HEAD OF THE 5.0MM LOCKING SCREW. THE SURGEON NEEDED TO REMOVE THE SCREW THAT WAS PUT IN THE PATIENT¿S LEG USING THIS SCREWDRIVER AS IT WON¿T OPEN TO RELEASE THE SCREW HEAD. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER/T25 SELF RETAINING/319MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14600128 ↗
• MalfunctionMay 6, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEON BROKE OFF 2 SCREWDRIVERS WHILE TRYING TO REMOVE THE LAST LOCKING-SCREW INSERTED IN AN LCP CONDYLAR PLATE. HE WAS STILL ABLE TO TURN THE PLATE TO THE SIDE TO INSERT THE A TFNA. IT IS UNCLEAR WHETHER THE PLATE IS STILL IN THE PATIENT. THERE WAS SURGICAL DELAY FOR AN UNSPECIFIED AMOUNT OF TIME. THIS REPORT IS FOR ONE (1) SCRDRIVER T25 SELF-HOLDING L319. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14309654 ↗
• MalfunctionMay 6, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEON BROKE OFF 2 SCREWDRIVERS WHILE TRYING TO REMOVE THE LAST LOCKING-SCREW INSERTED IN AN LCP CONDYLAR PLATE. HE WAS STILL ABLE TO TURN THE PLATE TO THE SIDE TO INSERT THE A TFNA. IT IS UNCLEAR WHETHER THE PLATE IS STILL IN THE PATIENT. THERE WAS SURGICAL DELAY FOR AN UNSPECIFIED AMOUNT OF TIME. THIS REPORT IS FOR ONE (1) SCRDRIVER T25 SELF-HOLDING L319 THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14309522 ↗