NA 357.399Recalls & reported problems

Summary

The FDA's MAUDE database contains 130 adverse event reports that list this exact device (DI 10886982196248), received between Nov 17, 2014 and Sep 25, 2026 — classified as 1 death, 22 injuries, 107 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (73 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 130 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902492 ↗
• MalfunctionSep 25, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902491 ↗
• MalfunctionSep 25, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902480 ↗
• MalfunctionSep 25, 2026Material Deformation

  It was reported that the surgeon was inserting a prophylactic long TFNA nail into a patient. During insertion of the nail it was noted that the patient had hard bone and the nail was difficult to insert. The issue occurred when they used the 6/9mm step drill bit ¿ 03.037.022. The tip of the drill bit broke off in the patient after the drill bit was passed through the insertion handle, aiming arm and nail. There was no issues with insertion of the 10mm cannulated drill (03.037.021) bit prior to the 6/9mm step drill bit. The staff switched out the insertion handle, aiming arm and other relevant instrumentation and the case was completed without incident. The fragments in the patient were able to be retrieved. The 3.2mm guide wire (357.399) was bent when they inspected it after removing it from the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902464 ↗
• MalfunctionMay 13, 2026Device-Device Incompatibility

  IT WAS DETECTED DURING SURGERY THAT THE OUTLET HOLE OF THE GUIDE IS SMALLER AND DOES NOT ALLOW THE PIN TO PASS THROUGH. IT WAS COMPARED WITH A PART OF THE SAME PRODUCT CODE, AND THE PIN DOES PASS THROUGH THAT PART CORRECTLY. THERE WAS NO REPORTED PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25164266 ↗
• MalfunctionApr 7, 2026Material Deformation

  THE PIECE WAS BENT DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24799803 ↗
• MalfunctionFeb 26, 2026Material Deformation

  IT WAS REPORTED THE HANDLE FOR THE HAND REAMER BROKE WHEN STRUCK WITH A HAMMER. THE REAMER HAD ALREADY SERVED ITS PURPOSE SO NO FURTHER ACTION WAS REQUIRED. IT WAS ALSO REPORTED THAT TWO (2) GUIDE NEEDLES WERE BENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY OR CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24458363 ↗
• MalfunctionFeb 26, 2026Material Deformation

  IT WAS REPORTED THE HANDLE FOR THE HAND REAMER BROKE WHEN STRUCK WITH A HAMMER. THE REAMER HAD ALREADY SERVED ITS PURPOSE SO NO FURTHER ACTION WAS REQUIRED. IT WAS ALSO REPORTED THAT TWO (2) GUIDE NEEDLES WERE BENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY OR CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24458330 ↗
• MalfunctionJan 12, 2026Material Deformation

  IT WAS REPORTED THAT THE PACKAGING WAS DAMAGED AND THE GUIDES WERE BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24036860 ↗
• MalfunctionJan 12, 2026Material Deformation

  THE PACKAGING WAS DAMAGED AND THE GUIDES WERE BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24036788 ↗
• MalfunctionJan 6, 2026Material Deformation

  IT WAS REPORTED THAT THE GUIDEWIRE Ø3.2 L400 LOST STRENGTH DURING USE, PREVENTING IT FROM BEING USED WITH THE THREADED GUIDE. THE EVENT OCCURRED INTRA-OPERATIVELY. THE COMPLAINT NOTES THAT THE DEVICE WAS DEFORMED OR BENT, BUT THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT, AND NO SIGNS, SYMPTOMS, OR PATIENT INVOLVEMENT WERE IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23973420 ↗
• MalfunctionDec 23, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THERE WERE THREE BENT GUIDEWIRES. THE GUIDEWIRES WERE STRAIGHTENED IN ORDER TO BE USED DURING THE INTERVENTION. SOME MINUTES OF SURGICAL DELAY. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23878794 ↗
• MalfunctionDec 23, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THERE WERE THREE BENT GUIDEWIRES. THE GUIDEWIRES WERE STRAIGHTENED IN ORDER TO BE USED DURING THE INTERVENTION. SOME MINUTES OF SURGICAL DELAY. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23878793 ↗
• MalfunctionDec 23, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THERE WERE THREE BENT GUIDEWIRES. THE GUIDEWIRES WERE STRAIGHTENED IN ORDER TO BE USED DURING THE INTERVENTION. SOME MINUTES OF SURGICAL DELAY. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23878792 ↗
• MalfunctionOct 20, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE TO RETUNNEL THE FEMUR BECAUSE IT LACKS A SPINAL CANAL, THE HANDLE OF THE #6 MANUAL SPINAL CORD REAMER BROKE BECAUSE THE CANAL WAS COMPLETELY OBLITERATED AND HARD. ALSO, DURING THE INITIAL OPENING OF THE ENTRANCE, THE 3.2MM GUIDE OF THE EQUIPMENT BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23335875 ↗
• MalfunctionAug 25, 2025Material Deformation; Material Deformation

  IT WAS REPORTED A THREADED GUIDE WIRE 3.2 IS DEFORMED. EVENT WAS NOTED PRE OPERATIVELY. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22891505 ↗
• MalfunctionMay 2, 2025Material Deformation; Material Deformation

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE SURGERY WAS SUCCESSFUL. NO SURGICAL DELAY REPORTED. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THERE WAS NO ALLEGATION AGAINST THE LAG SCREW, NAILS AND HELICAL BLADE.

  Patient problems: Insufficient Information

  MAUDE report 21952700 ↗
• MalfunctionApr 23, 2025Manufacturing, Packaging or Shipping Problem; Material Deformation; Manufacturing, Packaging or Shipping Problem; Material Deformation

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025. THE GUIDE WIRES SHOULD HAVE COME AS FIVE UNITS OF 3.2 L400 GUIDE NEEDLE, HOWEVER, ONLY FOUR WERE PRESENT. DURING THE PROCEDURE, ONE WAS USED AND BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21893886 ↗
• MalfunctionMar 31, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2025. AN OLIVE-SHAPED GUIDEWIRE BENT IN THE SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 21731439 ↗
• MalfunctionFeb 6, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT ORIF SURGERY WITH THE PRODUCTS IN QUESTION. IN THE SURGERY, THE GUIDE PIN WAS INSERTED USING THE PRODUCTS IN QUESTION, BUT IT DID NOT PASS THROUGH THE INTRAMEDULLARY NAIL AND SLIPPED FORWARD AND COULD NOT BE INSERTED IN THE PROPER DIRECTION. THE GUIDE PIN WAS INSERTED BY TILTING THE AIMING ARM BACKWARD, BUT IT SLIPPED FORWARD AGAIN AND COULD NOT BE INSERTED. THE ARM WAS REPOSITIONED, BUT IT WAS LED TOWARD THE GUIDE PIN THAT WAS ALREADY OPEN AND COULD NOT BE INSERTED. SINCE THE GUIDE PIN WAS NOT INSERTED IN THE CORRECT DIRECTION, WE CHANGED THE SCREW POSITION TO THE POSITION OF THE DOWNSTROKE AND TRANSVERSE INSTEAD OF FIXING THE RECONTOURING MODE. THE REASONS FOR THE FAILURE WERE THAT THE INTRAMEDULLARY NAIL WAS PLACED IN A PATIENT WITH A TIGHT MEDULLARY CAVITY, THE GUIDE PIN WAS GUIDED IN THE DIRECTION OF THE GUIDE PIN THAT WAS PLACED FIRST, THE POSITION OF THE AIMING ARM WAS NOT CHANGED MUCH BECAUSE THE INTRAMEDULLARY NAIL WAS PLACED TIGHTLY, AND THE SLEEVE MAY HAVE BEEN SLIGHTLY DEFLECTED.

  Patient problems: Insufficient Information

  MAUDE report 21321677 ↗
• MalfunctionDec 31, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT THE PROCEDURE FOR IPSILATERAL FEMORAL NECK AND SHAFT FRACTURE USING J&J MEDTECH FEMORAL RECON NAIL. BEFORE INSERTING THE IMPLANTS, SURGEON HAD CHECKED TO ENSURE THE WIRE IS ABLE TO PASS THROUGH THE NAIL WITHOUT ANY OBSTACLES. HOWEVER, WHEN THE SURGEON INSERTED THE GUIDE WIRE TO ONE OF THE NAIL HOLES, THE 3.2MM GUIDE WIRE COULD NOT PASS THROUGH SMOOTHLY AND IT FELT LIKE IT WAS HITTING THE NAIL WALL. AFTER MULTIPLE ATTEMPTS, SURGEON HAD TO COMPLETE THE SURGERY WITH THE MISSED A NAIL TECHNIQUE. THERE WAS 120 MINUTES OF SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 21048772 ↗
• InjuryOct 7, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED ON (B)(6) 2024, 2/3 OF THE BASIC INSTRUMENTS OF THE TN ADVANCED WERE NOT SENT. THE EVENT WAS REPORTED BY THE TA WHEN THE PATIENT WAS ALREADY UNDER ANESTHESIA. IT SHOULD HAVE BEEN TAKEN OUT OF THE WAREHOUSE AS CODE BLUE TO BE DELIVERED.

  Patient problems: Insufficient Information

  MAUDE report 20391002 ↗
• InjuryOct 7, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED ON SEPTEMBER 19, 2024, 2/3 OF THE BASIC INSTRUMENTS OF THE TN ADVANCED WERE NOT SENT. THE EVENT WAS REPORTED BY THE TA WHEN THE PATIENT WAS ALREADY UNDER ANESTHESIA. IT SHOULD HAVE BEEN TAKEN OUT OF THE WAREHOUSE AS CODE BLUE TO BE DELIVERED.

  Patient problems: Insufficient Information

  MAUDE report 20389486 ↗
• InjuryOct 7, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED ON (B)(6) 2024, 2/3 OF THE BASIC INSTRUMENTS OF THE TN ADVANCED WERE NOT SENT. THE EVENT WAS REPORTED BY THE TA WHEN THE PATIENT WAS ALREADY UNDER ANESTHESIA. IT SHOULD HAVE BEEN TAKEN OUT OF THE WAREHOUSE AS CODE BLUE TO BE DELIVERED.

  Patient problems: Insufficient Information

  MAUDE report 20387270 ↗
• InjuryOct 7, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED ON (B)(6) 2024, 2/3 OF THE BASIC INSTRUMENTS OF THE TN ADVANCED WERE NOT SENT. THE EVENT WAS REPORTED BY THE TA WHEN THE PATIENT WAS ALREADY UNDER ANESTHESIA. IT SHOULD HAVE BEEN TAKEN OUT OF THE WAREHOUSE AS CODE BLUE TO BE DELIVERED.

  Patient problems: Insufficient Information

  MAUDE report 20386001 ↗