NA 03.045.003Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10886982292506), received between Jul 25, 2022 and Sep 30, 2026 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (9 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Material Twisted/Bent

  It was reported that the Driving Cap f/Insertion Handle, Multihole Drill Sleeve, Trocar yell, ScrDriver-hex 5 flex cann, Extract-Instr f/TFNA Helical Blade+Scr, ScrDriver short XL25, ScrDriver w/Quick-Coupl hex 12 short XL2, Hand lrg cann w/Quick-Coupl Hex12, ConnecScr f/TFNA Helical Blade+Scr, and ScrDriver Shaft self-holding L165 f/Star were associated with wear-related and deformation issues. The reported failures included stripped or worn threads that did not engage securely, deformed holes that made guide wire passage difficult, a bent trocar that did not fit the cannula properly, dull screwdriver features that did not seat securely or function properly, and a handpiece that no longer clicked into screwdriver shafts. There was no patient involvement. The complaint devices were retained by the customer.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946044 ↗
• MalfunctionSep 22, 2026Contamination /Decontamination Problem

  It was reported that the instrument was dirty. There was no reported patient or user harm. Item was cleaned again and is back on the Loaner Set.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50854936 ↗
• MalfunctionMay 4, 2026Material Twisted/Bent

  IT WAS REPORTED THAT STRIPPED DRIVERS - NEED REPLACEMENTS. GOOD BONE HAS TORQUE SCREWDRIVERS ALONG WITH HANDLES. THERE WAS NO PATIENT STATUS OR OUTCOME OR CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25067003 ↗
• MalfunctionMay 4, 2026Material Twisted/Bent

  IT WAS REPORTED THAT STRIPPED DRIVERS - NEED REPLACEMENTS. GOOD BONE HAS TORQUE SCREWDRIVERS ALONG WITH HANDLES. THERE WAS NO PATIENT STATUS OR OUTCOME OR CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25066999 ↗
• MalfunctionApr 22, 2026Material Twisted/Bent

  IT WAS REPORTED THAT DRIVERS ARE STRIPPED AND NEED REPLACEMENTS. GOOD BONE HAS TORQUE SCREWDRIVERS ALONG WITH HANDLES. THERE WAS NO PATIENT STATUS OR OUTCOME OR CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24958179 ↗
• MalfunctionNov 10, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE SCREWDRIVER TIP STRIPPED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23512626 ↗
• MalfunctionSep 15, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON FEMUR WITH LCP BROAD PLATE. AFTER THE SURGERY, PSEUDOUNION WAS CONFIRMED. THE PATIENT UNDERWENT A REVISION SURGERY FOR FEMORAL SHAFT PSEUDOUNION WITH A 10MM-340MM RFNA AND THE PRODUCTS IN QUESTION. IN THE SURGERY, THE LOCKING SCREW IN QUESTION WAS INSERTED INTO THE SECOND SCREW HOLE FROM THE PROXIMAL END. A RETENTION PIN SHORT WAS ATTACHED TO A SCREWDRIVER SHORT IN THE USUAL WAY, AND THE SCREW WAS TIGHTENED. HOWEVER, THE SURGEON HAD DIFFICULTY INSERTING THE SCREW DUE TO THE HARDNESS OF THE BONE AND A SLIGHT MISALIGNMENT IN THE DIRECTION OF SCREW INSERTION. WHEN CHECKING THE IMAGE TO CONFIRM THE SCREW INSERTION DEPTH MIDWAY THROUGH, IT WAS CONFIRMED THAT THE DRIVER HAD COME OFF THE SCREW. WHEN THE SCREW WAS REMOVED, IT WAS CONFIRMED THAT THE THREADED PORTION OF THE RETENTION PIN SHORT HAD BROKEN OFF WHILE STILL INSIDE THE HEAD. A SCREW OF THE SAME LENGTH WAS INSERTED USING A LONG SCREWDRIVER AND RETENTION PIN, AND THE OPERATION WAS COMPLETED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE SURGEON'S OPINION WAS THAT THE BREAKAGE WAS LIKELY CAUSED BY THE STRONG FORCE USED TO FORCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23050594 ↗
• MalfunctionAug 18, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN ORIF SURGERY VIA TNA FOR TIBIAL SHAFT FRACTURE ON TIBIA WITH THE PRODUCTS IN QUESTION. IN THE SURGERY, A RADIOLUCENT WAS USED TO INSERT THE DISTAL SCREWS, BUT WHEN INSERTING THE LAST SCREW (THE SECOND ML HOLE FROM THE DISTAL END), THE RETENTION PIN BROKE AND THE TIP OF THE RETENTION PIN REMAINED INSIDE THE SCREW HEAD. SINCE IT COULD BE USED AS A NORMAL SCREWDRIVER, THE SCREW WAS REMOVED AND REPLACED WITH A NEW SCREW. SINCE NO BROKEN FRAGMENTS COULD BE CONFIRMED INSIDE THE BODY BY DIRECT VISION OR INTRAOPERATIVE IMAGING, IT WAS DETERMINED THAT THERE WERE NO REMAINING FRAGMENTS, AND THERE WAS NO PROBLEM WITH FIXATION, SO THE WOUND WAS CLOSED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22828817 ↗
• MalfunctionAug 4, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE SCREWDRIVER SHAFT. THE SCREWDRIVER SHAFT WAS USED ON A SURGERY USING TNA, AND THE SURGEON TRIED TO USE A LOCKING SCREW (5MM) BUT COULDN¿T. WHEN THEY CHECKED THE TIP OF THE SCREWDRIVER SHAFT, IT WAS FOUND THAT THE THREADED PART WAS BROKEN. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22702014 ↗
• MalfunctionJun 27, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THERE WAS ALLEGATION AGAINST THE TIBIAL NAIL, POLYMER JAMMED IN NAIL WHEN BACKING IT OUT. 8MM BROKE OFF POSTERIOR CORTEX. ANS DRIVERS ARE WARPED FROM USAGE. TNA DRIVE CAP PIN IS FALLING OUT FROM HAMMERING. THE PATIENT DID NOT EXPERIENCED ANY ADVERSE EVENT. THERE WAS NO PATIENT CONSEQUENCES. THIS COMPLAINT IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22347109 ↗
• MalfunctionJun 27, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THERE WAS ALLEGATION AGAINST THE TIBIAL NAIL, POLYMER JAMMED IN NAIL WHEN BACKING IT OUT. 8MM BROKE OFF POSTERIOR CORTEX. ANS DRIVERS ARE WARPED FROM USAGE. TNA DRIVE CAP PIN IS FALLING OUT FROM HAMMERING. THE PATIENT DID NOT EXPERIENCED ANY ADVERSE EVENT. THERE WAS NO PATIENT CONSEQUENCES. THIS COMPLAINT IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22346912 ↗
• MalfunctionJun 27, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THERE WAS ALLEGATION AGAINST THE TIBIAL NAIL, POLYMER JAMMED IN NAIL WHEN BACKING IT OUT. 8MM BROKE OFF POSTERIOR CORTEX. ANS DRIVERS ARE WARPED FROM USAGE. TNA DRIVE CAP PIN IS FALLING OUT FROM HAMMERING. THE PATIENT DID NOT EXPERIENCED ANY ADVERSE EVENT. THERE WAS NO PATIENT CONSEQUENCES. THIS COMPLAINT IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22346881 ↗
• MalfunctionJun 27, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THERE WAS ALLEGATION AGAINST THE TIBIAL NAIL, POLYMER JAMMED IN NAIL WHEN BACKING IT OUT. 8MM BROKE OFF POSTERIOR CORTEX. ANS DRIVERS ARE WARPED FROM USAGE. TNA DRIVE CAP PIN IS FALLING OUT FROM HAMMERING. THE PATIENT DID NOT EXPERIENCED ANY ADVERSE EVENT. THERE WAS NO PATIENT CONSEQUENCES. THIS COMPLAINT IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22346823 ↗
• MalfunctionFeb 13, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED STATES THAT NO OPERATION WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21376754 ↗
• MalfunctionFeb 13, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED STATES THAT NO OPERATION WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21376128 ↗
• MalfunctionJul 19, 2024Break; Crack; Contamination /Decontamination Problem; Device-Device Incompatibility; Break; Crack; Contamination /Decontamination Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEVICES WERE CHIPPING AND CRACKING AND WAS UNABLE TO STERILIZE OR ASSEMBLE, THEREFORE IT WAS UNABLE TO BE USE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SCREW DRIVER / CANNULATED SHORT / XL25. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19784623 ↗
• MalfunctionApr 10, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT (B)(6) 2024, THE PATIENT UNDERWENT AN RFNA IMPLANT SURGERY FOR PERI-TKA FRACTURE. WHILE DISTAL SIDE HOLE WAS SHAVED OFF, DRILL BIT INTERFERED WITH THE NAIL. WHILE PROXIMAL SIDE HOLE WAS SHAVED OFF, DRILL BIT INTERFERED WITH THE NAIL. WHILE HAMMERING, PAD¿S KNOB CAME OFF FROM AIMING DEVICE. WHEN SCREWDRIVER SELF-RETAINING XL25 AND RETENTION PIN TRIED TO BE INSERTED, SCREW DID NOT GRIP. WHEN ENDCAP WAS TRIED AND BEING INSERTED, ENDCAP DID NOT GRIP, THE SCREWDRIVER SELF-RETAINING XL25 AND RETENTION PIN WERE USED, AND THEY WERE SUCCESSFULLY INSERTED. RETENTION PIN BROKE OFF AND ITS BREAKAGE REMAINED TEMPORARILY. NO FURTHER INFORMATION IS AVAILABLE. THIS EVENT IS RELATED TO (B)(4). THIS REPORT IS FOR ONE (1) SCRDRIVER SHORT XL25 THIS IS REPORT 3 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19084209 ↗
• MalfunctionDec 4, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON NOVEMBER 10, 2023, THAT A SCREWDRIVER AND RETENTION PIN WAS DISCOVERED FAULTY IN STERILE PROCESSING DEPARTMENT (SPD). THE DEVICE WOULD NOT SCREW. IT IS UNKNOWN WHEN THE EVENT OCCURRED. NO KNOWN PATIENT INVOLVEMENT. THIS REPORT IS FOR SCREW DRIVER / CANNULATED SHORT / XL25 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18255743 ↗
• MalfunctionMay 3, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A REVISION PROCEDURE, A NAIL WAS INSERTED. WHILE INSERTING SCREWS, THE T HANDLE KEPT DISENGAGING FROM THE SHORT POWER SHAFT AND THE INNER CONNECTING ELEMENT BROKE FROM MALLEATING. AFTER NAILING A VA PPFX PROXIMAL FEMUR PLATE WAS POSITIONED, DUE TO THE NAIL. THE SCREW INSERTED WITH THE CANNULATED HEX DRIVER WAS STRIPPED DUE TO TORQUEING SCREWDRIVER. A T-HANDLE SWIVEL WRENCH WAS ALSO USED WITH THE ARTICULATING TENSION DEVICE, TWO BROKE OFF DUE TO PRESSURE SO A SOLID ONE WAS USED INSTEAD. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR ONE (1) SCRDRIVER SHORT XL25 THIS IS REPORT 4 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16865121 ↗
• MalfunctionApr 19, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A SHORT TFNA PROCEDURE WITH 125 DEGREE AIMING ARM, THE DRILL BIT HIT THE NAIL¿S DISTAL INTERLOCKS. THERE WAS DIFFICULTY INSERTING THE SCREW WITH THE LONG T25 POWER. WITH PERFECT CIRCLE TECHNIQUE THE SCREW WAS INSERTED. A MALLET WAS USED TO TAP ON THE DRIVER AND THE SCREWDRIVER HEAD SEEMED STRIPPED. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT OUTCOME. THIS REPORT INVOLVES ONE (1) SCREWDRIVER / SHORT / XL25. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16768955 ↗
• MalfunctionJan 13, 2023Device-Device Incompatibility; Device-Device Incompatibility

  THE SURGEON CONFIRMED BY X-RAY THAT THERE WERE NO PIECES LEFT IN THE PATIENT. IT WAS FURTHER ADDED THAT THERE WAS A MARK IN FRONT OF THE RETENTION PIN PROHIBITING HAMMERING. NO WARNING IN THE PROCEDURE MANUAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16158841 ↗
• MalfunctionOct 10, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT IM INTRAMEDULLARY NAILING. WHEN THE NAIL WAS INSERTED FULLY, THE NAIL WAS LOCKED PROXIMALLY. DURING DRILLING STATIC 1, IT HIT THE NAIL. SO THEY DID PERFECT CIRCLES PROXIMALLY TO COMPENSATE OF DRILL MISSING THE NAIL. WHILE TIGHTENING SCREW - SCREWDRIVER HEAD WAS WARPED FROM OVERTORQUEING. A SECOND SET WAS OPEN AND THE SECOND SCREWDRIVER WAS WARPED POSSIBLY DUE TO STRIPPED SCREW HEAD. THERE WAS A SURGICAL DELAY OF FIVE MINUTES. THERE WAS NO PATIENT STATUS, OUTCOME, AND CONSEQUENCES. THIS REPORT INVOLVES ONE (1) SCREWDRIVER / SHORT / XL25. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15574122 ↗
• MalfunctionOct 4, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2022 PATIENT UNDERWENT IM INTRAMEDULLARY NAILING. WHEN THE NAIL WAS INSERTED FULLY, THE NAIL WAS LOCKED PROXIMALLY. DURING DRILLING STATIC 1, IT HIT THE NAIL. PERFECT CIRCLES PROXIMALLY TO COMPENSATE FOR THE DRILL MISSING THE NAIL WAS DONE. WHILE TIGHTENING SCREW - SCREW DRIVER HEAD WAS WARPED FROM OVER TORQUEING. A SECOND SET WAS OPEN AND THE SECOND SCREWDRIVER WAS WARPED AS WELL. THERE WAS 5 MINUTES SURGICAL DELAY. THERE WAS NO PATIENT STATUS, OUTCOME AND CONSEQUENCES. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) SCREW DRIVER/CANNULATED SHORT/XL25. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15540628 ↗
• MalfunctionJul 25, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PARALLEL GUIDES HAD SOME SORT OF RESIDUE ON IT THAT WAS NOT ABLE TO BE WASHED OFF. POST-OP INSPECTION WAS OCCURRED. SCREW DRIVER WITH RETENTION WAS STRIPPED. BOTH T6 DRIVERS WERE CANDY CANED. TNA SUPRAPATELLAR GRAPHIC CASE HAD WHITE RESIDUE FROM WEAR POST OP INSPECTION. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) SCREW DRIVER / CANNULATED SHORT / XL25. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15094101 ↗