NA 03.010.523Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,208 adverse event reports that list this exact device (DI 10886982069351), received between Dec 21, 2016 and Sep 30, 2026 — classified as 10 injuries, 1,198 malfunctions.

The most frequently reported specific device problem is “Break” (1,089 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 1,208 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Device-Device Incompatibility; Material 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 50945795 ↗
• MalfunctionSep 28, 2026Break; Crack; Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50918196 ↗
• MalfunctionSep 22, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50858867 ↗
• MalfunctionSep 18, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829581 ↗
• MalfunctionSep 14, 2026Break; Corroded; Material Twisted/Bent

  It was reported several instruments were found broken, stripped, and rusted. No patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50753146 ↗
• MalfunctionSep 10, 2026No Apparent Adverse Event

  It was reported that device was received as Blind Unit with no reported product allegation. During manufacturer's investigation of the returned device it was identified that the shaft of the Driving Cap f/Insertion Handle was worn. In addition, the tip was broken, and the threaded area was stripped.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50717782 ↗
• MalfunctionSep 2, 2026Device-Device Incompatibility; Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50572697 ↗
• MalfunctionSep 2, 2026Device-Device Incompatibility; Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50572693 ↗
• MalfunctionSep 2, 2026Device-Device Incompatibility; Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50572691 ↗
• MalfunctionAug 31, 2026Insufficient Device Problem Information

  It was reported that the Hybrid Insertion handle was not able to accept driving cap for insertion handle due to what appeared to be something jammed or snap off in the relevant threaded hole. It created an inconvenience only. The case was proceeded successfully. There was no patient harm and no surgical delay.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50524668 ↗
• MalfunctionAug 24, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50418507 ↗
• MalfunctionAug 17, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50288149 ↗
• InjuryJun 30, 2026Break

  FRN DRIVING CAP SNAPPED IN HALF DURING INSERTION OF NAIL. DURING INSERTION OF THE NAIL, THE FEMORAL NECK BROKE; THE FRACTURE DID NOT EXIST PREVIOUSLY BEFORE IMPACTION. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY.

  Patient problems: Bone Fracture(s)

  MAUDE report 25669021 ↗
• MalfunctionJun 15, 2026Break; Material Twisted/Bent

  IT WAS REPORTED THE DRIVING CAP BROKE AND THREADED AND THE DRILL GUIDE BROKE DURING SURGERY. THE PROCEDURE WAS COMPLETED WITH NO DELAY OR HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25508005 ↗
• MalfunctionMay 11, 2026Break

  WHILST INSERTING THE NAIL THE DRIVING CAP THREADED PORTION LOOSENED AND BROKE OFF INSIDE THE RADIOLUCENT JIG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25143911 ↗
• MalfunctionMay 8, 2026Break

  IT WAS REPORTED THAT PATIENT UNDERWENT A TRAUMA PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE TFNA IMPACTOR BROKE WHERE THE THREADS ENGAGE THE IMPACTOR CONNECTING PIECE. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25126597 ↗
• MalfunctionMay 7, 2026Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE THE DRIVING CAP END/THREAD SNAPPED OFF IN THE INSERTION HANDLE WHEN THE SURGEON WAS IMPACTING A RECON NAIL INTO THE FEMUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25117177 ↗
• MalfunctionMay 7, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A POLY TRAUMA CASE, THE SURGEON RAN INTO SEVERAL ISSUES WITH BROKEN PRODUCT WHICH OCCURRED OR WAS NOTICED DURING THE PROCEDURE. ON INSERTION OF A TFNA NAIL INTO A SEVERELY COMMINUTED PROXIMAL THIRD FEMORAL SHAFT FRACTURE, THE IMPACTOR BROKE AND FELL ONTO THE FLOOR. THERE IS NO LOT NUMBER ASSOCIATED WITH THIS PRODUCT AS ALL NUMBERS HAVE BEEN FADED FROM THE IMPACTOR AFTER REPETITIVE USE. DURING THE SAME PROCEDURE, AFTER INSERTION OF THE TFNA LAG SCREW, THE LAG SCREW INSERTER AND THE LAG SCREW COUPLING DEVICE HAVE BECOME FUSED TOGETHER AND WILL NOT SEPARATE. IT WAS POSSIBLE TO DISLODGE THE DEVICE FROM THE TFNA SCREW, BUT THERE IS NO WAY TO NOW REMOVE THE COUPLING DEVICE FROM THE INSERTER. ON THE SAME PATIENT, A TIBIAL NAIL WAS ALSO COMPLETED. WHEN ATTEMPTING TO LOAD THE TNA ONTO THE INSERTION HANDLE, THEY WERE UNABLE TO ATTACH THE NAIL DUE TO THE TABS ON THE ATTACHMENT SITE BEING BENT. IT WOULD NOT ALLOW THE NAIL TO INSERT ONTO THE DEVICE APPROPRIATELY OR FOR THE CONNECTING BOLT TO INSERT TO REQUIRED DEPTH TO ATTACH TO THE TNA NAIL. TO SOLVE THIS ISSUE, THEY OPENED A SECOND TNA SET AND WERE ABLE TO SECURE A NAIL TO THIS DEVICE FOR INSERTION AND COMPLETE THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25116988 ↗
• MalfunctionMay 7, 2026Break; Illegible Information

  IT WAS REPORTED THAT DURING A POLY TRAUMA CASE, THE SURGEON RAN INTO SEVERAL ISSUES WITH BROKEN PRODUCT WHICH OCCURRED OR WAS NOTICED DURING THE PROCEDURE. ON INSERTION OF A TFNA NAIL INTO A SEVERELY COMMINUTED PROXIMAL THIRD FEMORAL SHAFT FRACTURE, THE IMPACTOR BROKE AND FELL ONTO THE FLOOR. THERE IS NO LOT NUMBER ASSOCIATED WITH THIS PRODUCT AS ALL NUMBERS HAVE BEEN FADED FROM THE IMPACTOR AFTER REPETITIVE USE. DURING THE SAME PROCEDURE, AFTER INSERTION OF THE TFNA LAG SCREW, THE LAG SCREW INSERTER AND THE LAG SCREW COUPLING DEVICE HAVE BECOME FUSED TOGETHER AND WILL NOT SEPARATE. IT WAS POSSIBLE TO DISLODGE THE DEVICE FROM THE TFNA SCREW, BUT THERE IS NO WAY TO NOW REMOVE THE COUPLING DEVICE FROM THE INSERTER. ON THE SAME PATIENT, A TIBIAL NAIL WAS ALSO COMPLETED. WHEN ATTEMPTING TO LOAD THE TNA ONTO THE INSERTION HANDLE, THEY WERE UNABLE TO ATTACH THE NAIL DUE TO THE TABS ON THE ATTACHMENT SITE BEING BENT. IT WOULD NOT ALLOW THE NAIL TO INSERT ONTO THE DEVICE APPROPRIATELY OR FOR THE CONNECTING BOLT TO INSERT TO REQUIRED DEPTH TO ATTACH TO THE TNA NAIL. TO SOLVE THIS ISSUE, THEY OPENED A SECOND TNA SET AND WERE ABLE TO SECURE A NAIL TO THIS DEVICE FOR INSERTION AND COMPLETE THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25116986 ↗
• MalfunctionMay 7, 2026Break; Illegible Information

  IT WAS REPORTED THAT DURING A POLY TRAUMA CASE, THE SURGEON RAN INTO SEVERAL ISSUES WITH BROKEN PRODUCT WHICH OCCURRED OR WAS NOTICED DURING THE PROCEDURE. ON INSERTION OF A TFNA NAIL INTO A SEVERELY COMMINUTED PROXIMAL THIRD FEMORAL SHAFT FRACTURE, THE IMPACTOR BROKE AND FELL ONTO THE FLOOR. THERE IS NO LOT NUMBER ASSOCIATED WITH THIS PRODUCT AS ALL NUMBERS HAVE BEEN FADED FROM THE IMPACTOR AFTER REPETITIVE USE. DURING THE SAME PROCEDURE, AFTER INSERTION OF THE TFNA LAG SCREW, THE LAG SCREW INSERTER AND THE LAG SCREW COUPLING DEVICE HAVE BECOME FUSED TOGETHER AND WILL NOT SEPARATE. IT WAS POSSIBLE TO DISLODGE THE DEVICE FROM THE TFNA SCREW, BUT THERE IS NO WAY TO NOW REMOVE THE COUPLING DEVICE FROM THE INSERTER. ON THE SAME PATIENT, A TIBIAL NAIL WAS ALSO COMPLETED. WHEN ATTEMPTING TO LOAD THE TNA ONTO THE INSERTION HANDLE, THEY WERE UNABLE TO ATTACH THE NAIL DUE TO THE TABS ON THE ATTACHMENT SITE BEING BENT. IT WOULD NOT ALLOW THE NAIL TO INSERT ONTO THE DEVICE APPROPRIATELY OR FOR THE CONNECTING BOLT TO INSERT TO REQUIRED DEPTH TO ATTACH TO THE TNA NAIL. TO SOLVE THIS ISSUE, THEY OPENED A SECOND TNA SET AND WERE ABLE TO SECURE A NAIL TO THIS DEVICE FOR INSERTION AND COMPLETE THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25116985 ↗
• MalfunctionMay 4, 2026Device-Device Incompatibility

  IT WAS REPORTED DURING THE PROCEDURE, THE SURGEON RAISED A CONCERN THAT THE DRIVING CAP WAS NOT ATTACHING SECURELY TO THE INSERTION HANDLE, NOTING THAT IMPROPER ATTACHMENT HAS PREVIOUSLY LED TO BREAKAGES. HOWEVER, BOTH THE DRIVING CAP AND THE INSERTION HANDLE USED IN THIS CASE WERE NEW. AN ATTEMPT WAS MADE TO REPLACE THE DRIVING CAP, BUT THE REPLACEMENT EXHIBITED THE SAME ISSUE. NO SUCH PROBLEMS HAVE BEEN OBSERVED WITH OLDER INSTRUMENTS. WHEN AN OLDER DRIVING CAP WAS TESTED WITH THE NEW INSERTION HANDLE, IT ATTACHED SECURELY WITHOUT ANY ISSUES. ADDITIONALLY, THE SAME ISSUE HAS BEEN REPORTED IN OTHER SETS WITH NEWLY REPLACED DRIVING CAPS. NO PATIENT HARM. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25067270 ↗
• MalfunctionMay 4, 2026Device-Device Incompatibility

  IT WAS REPORTED DURING THE PROCEDURE, THE SURGEON RAISED A CONCERN THAT THE DRIVING CAP WAS NOT ATTACHING SECURELY TO THE INSERTION HANDLE, NOTING THAT IMPROPER ATTACHMENT HAS PREVIOUSLY LED TO BREAKAGES. HOWEVER, BOTH THE DRIVING CAP AND THE INSERTION HANDLE USED IN THIS CASE WERE NEW. AN ATTEMPT WAS MADE TO REPLACE THE DRIVING CAP, BUT THE REPLACEMENT EXHIBITED THE SAME ISSUE. NO SUCH PROBLEMS HAVE BEEN OBSERVED WITH OLDER INSTRUMENTS. WHEN AN OLDER DRIVING CAP WAS TESTED WITH THE NEW INSERTION HANDLE, IT ATTACHED SECURELY WITHOUT ANY ISSUES. ADDITIONALLY, THE SAME ISSUE HAS BEEN REPORTED IN OTHER SETS WITH NEWLY REPLACED DRIVING CAPS. NO PATIENT HARM. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25067150 ↗
• MalfunctionMay 1, 2026Device-Device Incompatibility

  IT WAS REPORTED DURING THE PROCEDURE, THE SURGEON RAISED A CONCERN THAT THE DRIVING CAP WAS NOT ATTACHING SECURELY TO THE INSERTION HANDLE, NOTING THAT IMPROPER ATTACHMENT HAS PREVIOUSLY LED TO BREAKAGES. HOWEVER, BOTH THE DRIVING CAP AND THE INSERTION HANDLE USED IN THIS CASE WERE NEW. AN ATTEMPT WAS MADE TO REPLACE THE DRIVING CAP, BUT THE REPLACEMENT EXHIBITED THE SAME ISSUE. NO SUCH PROBLEMS HAVE BEEN OBSERVED WITH OLDER INSTRUMENTS. WHEN AN OLDER DRIVING CAP WAS TESTED WITH THE NEW INSERTION HANDLE, IT ATTACHED SECURELY WITHOUT ANY ISSUES. ADDITIONALLY, THE SAME ISSUE HAS BEEN REPORTED IN OTHER SETS WITH NEWLY REPLACED DRIVING CAPS. NO PATIENT HARM. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25056764 ↗
• MalfunctionApr 30, 2026Device-Device Incompatibility

  IT WAS REPORTED DURING THE PROCEDURE, THE SURGEON RAISED A CONCERN THAT THE DRIVING CAP WAS NOT ATTACHING SECURELY TO THE INSERTION HANDLE, NOTING THAT IMPROPER ATTACHMENT HAS PREVIOUSLY LED TO BREAKAGES. HOWEVER, BOTH THE DRIVING CAP AND THE INSERTION HANDLE USED IN THIS CASE WERE NEW. AN ATTEMPT WAS MADE TO REPLACE THE DRIVING CAP, BUT THE REPLACEMENT EXHIBITED THE SAME ISSUE. NO SUCH PROBLEMS HAVE BEEN OBSERVED WITH OLDER INSTRUMENTS. WHEN AN OLDER DRIVING CAP WAS TESTED WITH THE NEW INSERTION HANDLE, IT ATTACHED SECURELY WITHOUT ANY ISSUES. ADDITIONALLY, THE SAME ISSUE HAS BEEN REPORTED IN OTHER SETS WITH NEWLY REPLACED DRIVING CAPS. NO PATIENT HARM. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25043272 ↗
• MalfunctionApr 13, 2026Break

  IT WAS REPORTED DURING AN FRNA CASE, THE DRIVING CAP BROKE INSIDE OF THE INSERTION HANDLE. BOTH PIECES ARE NOW DEFECTIVE AND REPLACEMENTS ARE NEEDED. IT DID NOT DELAY THE CASE AT ALL AS WE HAD ANOTHER SET. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24861593 ↗