NA 03.010.070Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10886982067425), received between Apr 18, 2017 and Mar 26, 2026 — classified as 1 injury, 47 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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. 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 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026Material Deformation

  IT WAS REPORTED THAT THE TROCAR IS BENT. THERE WAS NO REPORTED PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24699039 ↗
• MalfunctionMar 20, 2026Material Deformation

  IT WAS REPORTED ON AN UNKNOWN DATE THAT SEVERAL DEPTH GAGES WERE BENT/NO LONGER ACCURATE. THE VA GUIDES WERE WEARING DOWN AND NOT STAYING IN VA HOLES DURING DRILLING WITHOUT ASSISTANCE. THE SCREWDRIVER SHAFTS WERE WORN DOWN. THE USF HANDLES WERE SPINNING ON THE SCREW WHEN THE SURGEON WAS TIGHTENING DOWN SCREWS. THE TROCARS WERE BENT/UNSTABLE. THERE WAS NO SURGICAL DELAY. ACTION WAS TAKEN BY REMOVING THE ITEMS FROM SERVICE, SAME INSTRUMENTS FROM OTHER TRAYS WERE USED INSTEAD. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO FRAGMENTS GENERATED WITH NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24652840 ↗
• MalfunctionMar 20, 2026Material Deformation

  IT WAS REPORTED ON AN UNKNOWN DATE THAT SEVERAL DEPTH GAGES WERE BENT/NO LONGER ACCURATE. THE VA GUIDES WERE WEARING DOWN AND NOT STAYING IN VA HOLES DURING DRILLING WITHOUT ASSISTANCE. THE SCREWDRIVER SHAFTS WERE WORN DOWN. THE USF HANDLES WERE SPINNING ON THE SCREW WHEN THE SURGEON WAS TIGHTENING DOWN SCREWS. THE TROCARS WERE BENT/UNSTABLE. THERE WAS NO SURGICAL DELAY. ACTION WAS TAKEN BY REMOVING THE ITEMS FROM SERVICE, SAME INSTRUMENTS FROM OTHER TRAYS WERE USED INSTEAD. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO FRAGMENTS GENERATED WITH NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24652828 ↗
• MalfunctionMar 20, 2026Material Deformation

  IT WAS REPORTED ON AN UNKNOWN DATE THAT SEVERAL DEPTH GAGES WERE BENT/NO LONGER ACCURATE. THE VA GUIDES WERE WEARING DOWN AND NOT STAYING IN VA HOLES DURING DRILLING WITHOUT ASSISTANCE. THE SCREWDRIVER SHAFTS WERE WORN DOWN. THE USF HANDLES WERE SPINNING ON THE SCREW WHEN THE SURGEON WAS TIGHTENING DOWN SCREWS. THE TROCARS WERE BENT/UNSTABLE. THERE WAS NO SURGICAL DELAY. ACTION WAS TAKEN BY REMOVING THE ITEMS FROM SERVICE, SAME INSTRUMENTS FROM OTHER TRAYS WERE USED INSTEAD. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO FRAGMENTS GENERATED WITH NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24652780 ↗
• MalfunctionMar 20, 2026Material Deformation

  IT WAS REPORTED ON AN UNKNOWN DATE THAT SEVERAL DEPTH GAGES WERE BENT/NO LONGER ACCURATE. THE VA GUIDES WERE WEARING DOWN AND NOT STAYING IN VA HOLES DURING DRILLING WITHOUT ASSISTANCE. THE SCREWDRIVER SHAFTS WERE WORN DOWN. THE USF HANDLES WERE SPINNING ON THE SCREW WHEN THE SURGEON WAS TIGHTENING DOWN SCREWS. THE TROCARS WERE BENT/UNSTABLE. THERE WAS NO SURGICAL DELAY. ACTION WAS TAKEN BY REMOVING THE ITEMS FROM SERVICE, SAME INSTRUMENTS FROM OTHER TRAYS WERE USED INSTEAD. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO FRAGMENTS GENERATED WITH NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24652776 ↗
• MalfunctionMar 20, 2026Material Deformation

  IT WAS REPORTED ON AN UNKNOWN DATE THAT SEVERAL DEPTH GAGES WERE BENT/NO LONGER ACCURATE. THE VA GUIDES WERE WEARING DOWN AND NOT STAYING IN VA HOLES DURING DRILLING WITHOUT ASSISTANCE. THE SCREWDRIVER SHAFTS WERE WORN DOWN. THE USF HANDLES WERE SPINNING ON THE SCREW WHEN THE SURGEON WAS TIGHTENING DOWN SCREWS. THE TROCARS WERE BENT/UNSTABLE. THERE WAS NO SURGICAL DELAY. ACTION WAS TAKEN BY REMOVING THE ITEMS FROM SERVICE, SAME INSTRUMENTS FROM OTHER TRAYS WERE USED INSTEAD. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO FRAGMENTS GENERATED WITH NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24652692 ↗
• MalfunctionMar 20, 2026Material Deformation

  IT WAS REPORTED ON AN UNKNOWN DATE THAT SEVERAL DEPTH GAGES WERE BENT/NO LONGER ACCURATE. THE VA GUIDES WERE WEARING DOWN AND NOT STAYING IN VA HOLES DURING DRILLING WITHOUT ASSISTANCE. THE SCREWDRIVER SHAFTS WERE WORN DOWN. THE USF HANDLES WERE SPINNING ON THE SCREW WHEN THE SURGEON WAS TIGHTENING DOWN SCREWS. THE TROCARS WERE BENT/UNSTABLE. THERE WAS NO SURGICAL DELAY. ACTION WAS TAKEN BY REMOVING THE ITEMS FROM SERVICE, SAME INSTRUMENTS FROM OTHER TRAYS WERE USED INSTEAD. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO FRAGMENTS GENERATED WITH NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24652524 ↗
• MalfunctionMar 19, 2026Material Deformation

  IT WAS REPORTED THAT SEVERAL DEPTH GAGES ARE BENT/NO LONGER ACCURATE. VA GUIDES WEARING DOWN AND NOT STAYING IN VA HOLES DURING DRILLING WITHOUT ASSISTANCE. SCREWDRIVER SHAFTS WORN DOWN. USF HANDLES ARE SPINNING ON SCREW WHEN SURGEON IS TIGHTENING DOWN SCREWS. TROCARS ARE BENT/UNSTABLE. NO SURGICAL DELAY. ACTION WAS TAKEN BY REMOVING THE ITEMS FROM SERVICE, SAME INSTRUMENTS FROM OTHER TRAYS WERE USED INSTEAD. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24642698 ↗
• MalfunctionMar 19, 2026Material Deformation

  IT WAS REPORTED THAT SEVERAL DEPTH GAGES ARE BENT/NO LONGER ACCURATE. VA GUIDES WEARING DOWN AND NOT STAYING IN VA HOLES DURING DRILLING WITHOUT ASSISTANCE. SCREWDRIVER SHAFTS WORN DOWN. USF HANDLES ARE SPINNING ON SCREW WHEN SURGEON IS TIGHTENING DOWN SCREWS. TROCARS ARE BENT/UNSTABLE. NO SURGICAL DELAY. ACTION WAS TAKEN BY REMOVING THE ITEMS FROM SERVICE, SAME INSTRUMENTS FROM OTHER TRAYS WERE USED INSTEAD. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24642686 ↗
• MalfunctionJan 27, 2026Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE, THERE WERE BENT DEPTH GAUGES. DURING A CASE, A TROCAR WAS USED AS A REDUCTION TOOL AND WAS BENT IN THE PROCESS. OPERACE TREPHINES WERE USED FOR BROKEN SCREWS AND DID NOT WORK. NO SURGERY DELAYED DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24189045 ↗
• MalfunctionJan 27, 2026Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE, THERE WERE BENT DEPTH GAUGES. DURING A CASE, A TROCAR WAS USED AS A REDUCTION TOOL AND WAS BENT IN THE PROCESS. OPERACE TREPHINES WERE USED FOR BROKEN SCREWS AND DID NOT WORK. NO SURGERY DELAYED DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24189041 ↗
• MalfunctionJan 2, 2026Material Deformation

  IT WAS REPORTED THAT A TNA DRIVING CAP BROKE AND GREEN TROCAR BENT. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23945229 ↗
• MalfunctionJun 25, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT THE TFNA AIMING ARM AND ALL ASSOCIATED PIECES NEED TO BE REPLACED DUE TO DIFFICULTY AND ABNORMALLY HIGH RESISTANCE EXPERIENCED WHEN INSERTING GUIDE SLEEVES. THEY APPEARED TO GET JAMMED AND STUCK BEFORE FULL INSERTION WAS ACHIEVED. THIS WAS DISCOVERED DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22327537 ↗
• MalfunctionJun 24, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  TFNA AIMING ARM AND ALL ASSOCIATED PIECES NEED TO BE REPLACED DUE TO DIFFICULTY AND ABNORMALLY HIGH RESISTANCE EXPERIENCED WHEN INSERTING GUIDE SLEEVES. THEY APPEARED TO GET JAMMED AND STUCK BEFORE FULL INSERTION WAS ACHIEVED. THIS WAS DISCOVERED DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22320758 ↗
• MalfunctionApr 3, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE TROCAR WAS DISCOVERED TO HAVE A BEND AT THE END OF IT FOLLOWING A PROCEDURE ON (B)(6) 2025. THE DEVICE FUNCTIONED PROPERLY DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21764063 ↗
• MalfunctionJan 8, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6)2024, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR AN INTERTROCHANTERIC FRACTURE. THE SURGEON DRILLED THE MOST PROXIMAL HOLE AMONG THE DISTAL SCREW HOLES. THE DRILL BIT INTERFERED WITH THE HOLE. THE SURGEON CHECKED THE SIDES AND WAS ABLE TO INSERT THE DRILL BIT, SO THE SURGEON LEFT THE DRILL BIT IN PLACE. THE SURGEON DRILLED THE MOST DISTAL OBLIQUE LOCKING HOLE. THERE WAS NO INTERFERENCE BETWEEN A DRILL BIT AND THE OBLIQUE LOCKING HOLE, AND INSERTION OF A LOCKING SCREW WAS COMPLETED. THE SURGEON REMOVED THE DRILL BIT THAT WAS LEFT IN THE MOST PROXIMAL HOLE AMONG THE DISTAL SCREW HOLES AND INSERTED A LOCKING SCREW. THE SURGEON DRILLED THE DYNAMIC HOLE, WHICH IS THE HOLE IN THE MIDDLE. THE DRILL BIT INTERFERED WITH THE DYNAMIC HOLE. THE SURGEON DID NOT INSERT A LOCKING SCREW TO THE DYNAMIC HOLE AND COMPLETED THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN A THIRTY (30) MINUTE DELAY. PER THE SURGEON, IT WAS PRESUMED THAT THERE WAS RESISTANCE DURING NAIL INSERTION AND THAT THERE MAY NOT HAVE BEEN ENOUGH MEDULLARY REAMING; THERE WAS NO ALLEGATION AGAINST THE NAIL OR SCREWS. THE PATIENT OUTCOME WAS REPORTED AS STABL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21103362 ↗
• MalfunctionSep 17, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON SEP 5, 2024 THE DEVICE GOT BENT. THERE WAS NO OPERATION AND PATIENT INVOLVEMENT. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20237192 ↗
• MalfunctionFeb 12, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON 29-JANUARY-2024 WHILE PERFORMING A DEMO FOR STAFF, IT WAS DISCOVERED THAT THE 8.0/4.2MM DRILL SLEEVE WOULD NOT FIT DOWN THE 12.0/8.0MM PROTECTION SLEEVE. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 4.2MM TROCAR 210MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18685229 ↗
• MalfunctionJan 16, 2024Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SLEEVES ARE BENT FROM NORMAL WEAR AND TEAR. THERE WERE NO PATIENT OUTCOMES REPORTED. THIS REPORT IS FOR ONE (1) 4.2MM TROCAR 210MM THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18519152 ↗
• MalfunctionSep 21, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE SURGEON MENTIONED THAT WHEN USING OUR HAN HE OFTEN EXPERIENCES PROXIMAL TARGETING MISS ALIGNMENT FROM MEDIAL SIDE AS SHOWN IN OUR HINDFOOT ARTHRODESIS NAIL STG. HE STATED THAT IN SOME CASES THE INSTRUMENTATION TARGETS BETTER WHEN AIMING ARM IS ROTATED TO LATERAL SIDE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1)4.2MM TROCAR 210MM. THIS IS REPORT 5 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17788336 ↗
• MalfunctionSep 15, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2023 DURING POSTOPERATIVE INSPECTION OF A SET, IT WAS NOTED THAT THE NAIL EXTRACTION AND HAMMER GUIDE WERE COLD-WELDED TOGETHER. THE OTHER INSTRUMENTS WERE NOTED TO BE DEFORMED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1)TROCAR Ø4.2 F/03.010.065; THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17755000 ↗
• MalfunctionAug 14, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING SURGERY ON (B)(6), 2023, THE FRN 10X400 L GT WAS INSERTED INTO A HEAVIER PATIENT. WHEN INSERTING THE NAIL, THERE WAS RESISTANCE. ONCE THE NAIL WAS FULLY INSERTED, GREEN TRIPLE SLEEVES WERE INSERTED THROUGH THE JIG AND MALLETED. THE INNER TROCAR ENDED UP BENDING, SO IT WAS TAKEN OUT AND THEN DRILLED. THE DRILL BIT HIT THE NAIL, SO A NEW TRIPLE SLEEVE WAS INSERTED. THE DRILL BIT HIT THE NAIL AGAIN. THE NAIL WAS REMOVED, AND A TFNA WAS INSERTED INSTEAD WITH NO ISSUES. THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT ANY DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE 4.2MM TROCAR 210MM. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17542287 ↗
• MalfunctionAug 14, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2023, THE FRN 10X400 L GT WAS INSERTED INTO A HEAVIER PATIENT. WHEN INSERTING THE NAIL, THERE WAS RESISTANCE. ONCE THE NAIL WAS FULLY INSERTED, GREEN TRIPLE SLEEVES WERE INSERTED THROUGH THE JIG AND MALLETED. THE INNER TROCAR ENDED UP BENDING, SO IT WAS TAKEN OUT AND THEN DRILLED. THE DRILL BIT HIT THE NAIL, SO A NEW TRIPLE SLEEVE WAS INSERTED. THE DRILL BIT HIT THE NAIL AGAIN. THE NAIL WAS REMOVED, AND A TFNA WAS INSERTED INSTEAD WITH NO ISSUES. THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT ANY DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE 4.2MM TROCAR 210MM. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17542142 ↗
• MalfunctionAug 14, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2023, THE FRN 10X400 L GT WAS INSERTED INTO A HEAVIER PATIENT. WHEN INSERTING THE NAIL, THERE WAS RESISTANCE. ONCE THE NAIL WAS FULLY INSERTED, GREEN TRIPLE SLEEVES WERE INSERTED THROUGH THE JIG AND MALLETED. THE INNER TROCAR ENDED UP BENDING, SO IT WAS TAKEN OUT AND THEN DRILLED. THE DRILL BIT HIT THE NAIL, SO A NEW TRIPLE SLEEVE WAS INSERTED. THE DRILL BIT HIT THE NAIL AGAIN. THE NAIL WAS REMOVED, AND A TFNA WAS INSERTED INSTEAD WITH NO ISSUES. THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT ANY DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE 4.2MM TROCAR 210MM. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17542123 ↗
• MalfunctionMay 3, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PLATE STRIPPED DURING ATTACHMENT OF AIMING ARM WITH WRENCH. THE OPTERATOR WAS BENT DURING PROCESS DUE TO PRESSURE. RFNA AIMING ARM WAS CRACKED DURING MALLEATING. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) 4.2MM TROCAR 210MMT. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16864615 ↗