NA 03.043.005Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886982297150), received between Jan 14, 2022 and Apr 3, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (8 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT INSTRUMENT WON¿T PASS THROUGH PROTECTION SLEEVE FREELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24780274 ↗
• MalfunctionJan 16, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE TIBIA NAIL SLEEVE WAS PINCHED AND THE WIRE WAS UNABLE TO PASS THROUGH. THE PATIENT WAS NOT AFFECTED. THE SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24095016 ↗
• MalfunctionDec 29, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED DURING A TNA SP PROCEDURE, AS SURGEONS INSERTED THE PROTECTION SLEEVE (03.043.033S) TOGETHER WITH THE WIRE GUIDE 03.043.005, THE PROTECTION SEEMS NORMAL. UPON REMOVING THE WIRE GUIDE 03.043.005 FOR THE NEXT STEP, IT WAS SEEN FROM THE C-ARM PICTURES THAT THE PROTECTION SLEEVE SEEMS DEFORMED. AS SURGEON PROCEEDED WITH THE NEXT STEP, THEY FACED DIFFICULTY TO PASS THE 12MM FLEXIBLE DRILL BIT OVER THE GUIDE WIRE. ALONG THE STEPS, AS THEY TRIED TO REAM WITH THE INTRAMEDULLARY REAMER, THEY NEEDED TO EXERT EXTRA FORCE TO PUSH THE REAMER OVER THE KINK AS WELL AS TO PULL THE REAMER OUT. IT CAN BE SEEN THAT THE METAL COMPONENT IN THE PROTECTION SLEEVE WAS PULLED OUT FROM THE ORIGINAL POSITION AS WELL. THERE WAS NO HARM DONE TO PATIENT, BUT THE SURGERY WAS SLIGHTLY DELAYED DUE TO THE ITEMS STUCK IN THE PROTECTION SLEEVE. SURGERY WAS DELAYED ABOUT 30 MINUTES. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23905398 ↗
• MalfunctionJul 14, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT WHEN DOING A SUPRAPATELLAR NAIL, THE SURGEON ATTEMPTED TO PUT IN THE 3.2 GUIDE THROUGH THE WIRE GUIDE, AND IT WAS CATCHING. IT WOULD NOT SLIDE SMOOTHLY. IT WAS CATCHING AND SO IT DO NOT HOLD INTENSITY BECAUSE HE SLID IT THROUGH THE OTHER HOLE AND WAS ABLE TO ADAPT, BUT IT WAS FAULTY AT THIS POINT. IT DID NOT HOLD UP SURGERY NOR DID IT AFFECT PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22497107 ↗
• MalfunctionJan 21, 2025Corroded; Corroded

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, SPD STATED THAT THE DEVICE WAS RUSTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21202052 ↗
• MalfunctionJul 26, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN OPEN REDUCTION/INTERNAL FIXATION SURGERY TREATING THE TIBIA. WHEN THE 3.2 GUIDEWIRE WAS PASSED THROUGH THE SLEEVE, IT BECAME STUCK. THERE WAS NO IMPACT ON THE SURGERY BECAUSE ANOTHER GUIDE WIRE WAS USED. WHEN A NURSE TRIED TO PULL OUT THE STUCK GUIDEWIRE USING A POWER TOOL, THE POWER TOOL (TRS) IDLED. THE TRS APPEARS TO HAVE EMITTED HIGH TEMPERATURE DURING USE FOR REMOVING THE GUIDE WIRE FROM THE SLEEVE, AND THE NURSE TOUCHED THE GUIDE WIRE WITHOUT REALIZING THE GUIDE WIRE BECAME HEATED AND GOT BURNED THROUGH HIS/HER GLOVES. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE WIRE GUIDE / MULTIHOLE / LONG FOR NAILS Ø 8-11MM. THIS IS REPORT 1 OF 2 FOR (B)(4) . THIS REPORT IS RELATED TO (B)(4) , WHICH CAPTURES THE INVOLVED POWER TOOL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19837637 ↗
• 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)WIRE GUIDE / MULTIHOLE / LG NL 8-11 THIS IS REPORT 5 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18800809 ↗
• MalfunctionDec 14, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2023 AN ORTHOPEDIC SURGEON WAS PERFORMING A SUPRAPATELLAR TIBIAL NAIL. DURING THE PROCEDURE THE DOCTOR INSERTED A GUIDE WIRE OF 8-11MM DIAMETER NAIL. THE SURGEON INTRODUCED THE GUIDED WIRE SLEEVE BEHIND THE PATELLA TO GET A CERTAIN POINT FOR THE NAIL AND POSITIONED REVISE IN X-RAY WITH THE 2.2 MM GUIDE WIRE THROUGH CANNULATED WIRE SLEEVE UPON INTRODUCING GUIDED WIRE TOP OF THE TIBIA. THE GUIDE WIRE BECAME BENT INTO THE GUIDE WIRE SLEEVE. UPON SEEING THIS, THE GUIDE WIRE SLEEVE WAS REMOVED, THE SURGEON ATTEMPTED TO REMOVE THE GUIDE WIRE BUT WAS UNSUCCESSFUL. SO, THE SURGEON CONTINUED TO USE THE GUIDES SLEEVE AS SPECIFIC GUIDE WIRE FOR REST OF THE CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE (1) WIRE GUIDE / MULTIHOLE / LONG FOR NAILS Ø 8-11MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18326153 ↗
• MalfunctionDec 12, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON NOVEMBER 19, 2023 AN ORTHOPEDIC SURGEON WAS PERFORMING A SUPRAPATELLAR TIBIAL NAIL. DURING THE PROCEDURE THE DOCTOR INSERTED A GUIDE WIRE OF 8-11MM DIAMETER NAIL. THE SURGEON INTRODUCED THE GUIDED WIRE SLEEVE BEHIND THE PATELLA TO GET A CERTAIN POINT FOR THE NAIL AND POSITIONED REVISE IN X-RAY WITH THE 2.2 MM GUIDE WIRE THROUGH CANNULATED WIRE SLEEVE UPON INTRODUCING GUIDED WIRE TOP OF THE TIBIA. THE GUIDE WIRE BECAME BENT INTO THE GUIDE WIRE SLEEVE. UPON SEEING THIS, THE GUIDE WIRE SLEEVE WAS REMOVED, THE SURGEON ATTEMPTED TO REMOVE THE GUIDE WIRE BUT WAS UNSUCCESSFUL. SO, THE SURGEON CONTINUED TO USE THE GUIDES SLEEVE AS SPECIFIC GUIDE WIRE FOR REST OF THE CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE (1) WIRE GUIDE / MULTIHOLE / LONG FOR NAILS Ø 8-11MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18310170 ↗
• MalfunctionJun 7, 2023Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THE WIRE SLEEVE WAS DAMAGED AS IT WAS A VERY TIGHT JOINT TO TRY AND GET THE PROTECTIVE SLEEVE THROUGH. THE SURGEON USED LIGHT MALLOT TAPS TO TRY AND ADVANCE THE WIRE SLEEVE DOWN TO THE BONE. THE 3.2 WIRE NO LONGER PASSES THROUGH THE HOLES IN THE SLEEVE. THE PROTECTION SLEEVE WAS DISCARDED AND WIRE SLEEVE DAMAGED. PROCEDURE WAS COMPLETED SUCCESSFULLY USING A 2ND SET FOR A NEW WIRE SLEEVE. NO FRAGMENTS GENERATED. THIS REPORT IS FOR ONE (1) WIRE GUIDE / MULTIHOLE / LONG FOR NAILS Ø 8-11MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17080669 ↗
• MalfunctionJan 14, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT, THE TIP WAS BENT IN ONE OF THE CANNULAS NOT ALLOWING A WIRE TO PASS THROUGH IT. THIS REPORT IS FOR ONE (1) WIRE GUIDE / MULTIHOLE / LG NL 8-11. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13258434 ↗