T2 1806-0370Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 04546540196484), received between Sep 25, 2015 and Feb 6, 2026 — classified as 4 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2026Mechanical Jam

  IT WAS REPORTED THAT "BEFORE SURGERY THE STAFF WANTED TO TRY OUT THE NAIL. THE CONNECTED IT WITH TARGETING DEVICE AND IT WAS NOT POSSIBLE TO DISCONNECT THEM. DIFFERENT SYSTEM WAS USED FOR SURGERY".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24284033 ↗
• MalfunctionFeb 6, 2026Mechanical Jam

  IT WAS REPORTED THAT "BEFORE SURGERY THE STAFF WANTED TO TRY OUT THE NAIL. THE CONNECTED IT WITH TARGETING DEVICE AND IT WAS NOT POSSIBLE TO DISCONNECT THEM. DIFFERENT SYSTEM WAS USED FOR SURGERY".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24283905 ↗
• MalfunctionJun 23, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  AS REPORTED: "THE INSTRUMENTS, ONCE THE PATIENT HAD ALREADY BEEN ANESTHETIZED, WERE FOUND TO BE DEFECTIVE AND UNUSABLE. OUR AGENT HAD TO URGENTLY DELIVER ANOTHER INSTRUMENT, WHICH WAS WITHDRAWN IN AN EMERGENCY FROM ONE OF OUR DEPOSIT ACCOUNTS, CAUSING CONSIDERABLE INCONVENIENCE TO BOTH CUSTOMERS AND SIGNIFICANTLY LENGTHENING THE DURATION OF THE OPERATION." 5/27/2025 - UPON PRODUCT RETURN, A SECOND NAIL HOLDING SCREW WAS RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22310767 ↗
• MalfunctionMay 21, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  AS REPORTED: "THE INSTRUMENTS, ONCE THE PATIENT HAD ALREADY BEEN ANESTHETIZED, WERE FOUND TO BE DEFECTIVE AND UNUSABLE. OUR AGENT HAD TO URGENTLY DELIVER ANOTHER INSTRUMENT, WHICH WAS WITHDRAWN IN AN EMERGENCY FROM ONE OF OUR DEPOSIT ACCOUNTS, CAUSING CONSIDERABLE INCONVENIENCE TO BOTH CUSTOMERS AND SIGNIFICANTLY LENGTHENING THE DURATION OF THE OPERATION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22064177 ↗
• MalfunctionMay 13, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  AS REPORTED: "T2 TIBIA NAIL HOLDER BOLT REF 18060370 THAT NO LONGER FITS IN THE T2 TIBIA NAIL HOLDER REF 18061002."

  Patient problems: Insufficient Information

  MAUDE report 22011737 ↗
• MalfunctionApr 8, 2025Mechanical Jam; Mechanical Jam

  AS REPORTED: "INTRAOPERATIVELY, THE NAIL RETAINING PIN (1806-0370) COULD NO LONGER BE DETACHED FROM THE NAIL. THIS MEANT THAT THERE WAS A NON-DETACHABLE CONNECTION BETWEEN THE NAIL RETAINING PIN, THE NAIL ADAPTER 1806-1002) AND THE NAIL ITSELF. THE OPERATION HAD TO BE CONTINUED WITHOUT THE TARGETING DEVICE AND WAS COMPLETED MANUALLY. OP TIME EXTENDED (90 MIN), INCREASED RADIATION DUE TO HANDS-FREE LOCKING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21794743 ↗
• InjuryAug 23, 2024Mechanical Jam; Mechanical Jam

  THE SALES REP REPORTED THAT: "DURING THE OPERATION, THE SURGICAL TEAM WAS UNABLE TO COMPLETE THE PROCEDURE DUE TO A TECHNICAL PROBLEM WITH THE ANCILLARY PARTS. AFTER REAMING THE PATIENT'S TIBIA AND IDENTIFYING THE IMPLANT TO BE PLACED, THE OPERATORS WERE UNABLE TO CONTINUE THE PROCEDURE DUE TO A PROBLEM WITH THE ASSEMBLY AND DISASSEMBLY OF THE BOLT, NAIL HOLDER AND IMPLANT. THE BOLT AND NAIL HOLDER REMAINED ATTACHED, MAKING IT IMPOSSIBLE TO DISMANTLE THE IMPLANT ONCE THE PROCEDURE HAD BEEN COMPLETED. FOR SAFETY REASONS, THE OPERATORS PREFERRED NOT TO IMPLANT THE IMPLANT AND TO POSTPONE THE OPERATION TO A LATER DATE. INTERVENTION POSTPONED TO 07/31 INSTEAD OF 07/27. THE OPERATION WAS CARRIED OUT BY AN EXPERIENCED SURGICAL TEAM. THE ¿RECOVERY¿ OPERATION TOOK PLACE IN THE PRESENCE OF THE LOCAL SALES MANAGER, AND WENT SMOOTHLY. THE FAULTY EQUIPMENT WAS TAKEN BACK BY THE SALES REPRESENTATIVE FOR EXPERT EXAMINATION."

  Patient problems: Insufficient Information

  MAUDE report 20048257 ↗
• InjuryAug 22, 2024Mechanical Jam; Mechanical Jam

  THE SALES REP REPORTED THAT: "DURING THE OPERATION, THE SURGICAL TEAM WAS UNABLE TO COMPLETE THE PROCEDURE DUE TO A TECHNICAL PROBLEM WITH THE ANCILLARY PARTS. AFTER REAMING THE PATIENT'S TIBIA AND IDENTIFYING THE IMPLANT TO BE PLACED, THE OPERATORS WERE UNABLE TO CONTINUE THE PROCEDURE DUE TO A PROBLEM WITH THE ASSEMBLY AND DISASSEMBLY OF THE BOLT, NAIL HOLDER AND IMPLANT. THE BOLT AND NAIL HOLDER REMAINED ATTACHED, MAKING IT IMPOSSIBLE TO DISMANTLE THE IMPLANT ONCE THE PROCEDURE HAD BEEN COMPLETED. FOR SAFETY REASONS, THE OPERATORS PREFERRED NOT TO IMPLANT THE IMPLANT AND TO POSTPONE THE OPERATION TO A LATER DATE. INTERVENTION POSTPONED TO 07/31 INSTEAD OF 07/27. THE OPERATION WAS CARRIED OUT BY AN EXPERIENCED SURGICAL TEAM. THE ¿RECOVERY¿ OPERATION TOOK PLACE IN THE PRESENCE OF THE LOCAL SALES MANAGER, AND WENT SMOOTHLY. THE FAULTY EQUIPMENT WAS TAKEN BACK BY THE SALES REPRESENTATIVE FOR EXPERT EXAMINATION."

  Patient problems: Insufficient Information

  MAUDE report 20041293 ↗
• MalfunctionApr 17, 2023Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  CUSTOMER REPORTED THAT: "THIS DEVICE PRESENTS THE FOLLOWING ANOMALY: IMPOSSIBLE TO LOWER THE NAIL FIXING SCREW INTO THE NAIL, PREVENTING IT FROM BEING FIXED ON THE NAIL HOLDER."

  Patient problems: Insufficient Information

  MAUDE report 16751279 ↗
• MalfunctionDec 2, 2022Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  AS REPORTED: "THE THREAD OF THE T2 TIBIAL NAIL HOLDING SCREW NO LONGER ENGAGES THE PROXIMAL THREAD OF THE TIBIAL NAIL. NAIL CANNOT BE FIXED. IT HAD TO BE LOCKED SEVERAL TIMES FREEHAND, RENEWED INSTALLATION AND REMOVAL OF THE COMPLETE NAIL." THERE WAS A 2 MINUTE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15911881 ↗
• MalfunctionNov 8, 2022Mechanical Jam; Mechanical Jam

  AS REPORTED: "TIBIA NAIL T2 LOCKED WITH NAIL HOLDING SCREW. COLD WELDING. NAIL COULD NOT BE COMPLETELY FIXED WITH NAIL ADAPTER AND NAIL HOLDING SCREW."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15756376 ↗
• MalfunctionSep 5, 2022Mechanical Jam; Mechanical Jam

  AS REPORTED: "THE INCIDENT OCCURRED IN THE OPERATING ROOM ON (B)(6) 2022 AND CONCERNED THE PLACEMENT OF A T2 TIBIAL NAIL. AFTER THE NAIL WAS PLACED, IT WAS IMPOSSIBLE TO REMOVE THE NAIL ANCILLARY. THE FIXATION SCREW ASSEMBLY, TIBIA NAIL HANDLE AND NAIL SEIZED. THE NAIL HAD TO BE REMOVED FROM THE PATIENT (WITH THE HANDLE STILL PRESENT AT THE END) AND ANOTHER ONE HAD TO BE INSERTED (SMALLER SIZE, AS THERE IS ONLY ONE OF EACH SIZE) USING THE SECOND BOX OF ANCILLARY EQUIPMENT PRESENT IN THE OPERATING ROOM. THE OPERATION ENDED WELL FOR THE PATIENT, BUT THE PROCEDURE WAS LENGTHENED AND THE NAIL PLACED WAS SLIGHTLY SHORTER THAN INITIALLY PLANNED. THE NAIL - NAIL HANDLE DISASSEMBLY WAS PERFORMED AFTER THE PROCEDURE: THE NAIL TIP BROKE OFF AND SO DID THE FOLLOWING ANCILLARIES DUE TO THE FACT THAT THEY HAD TO BE FORCED OUT DUE TO SEIZURE. THE EXPLANTED NAIL, THE GIMBAL WRENCH, THE HANDLE AND THE FIXATION SCREW WERE RECOVERED AND DECONTAMINATED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15354703 ↗
• MalfunctionMay 24, 2022Difficult to Insert; Device Difficult to Setup or Prepare; Difficult to Insert; Device Difficult to Setup or Prepare

  AS REPORTED: "THE NAIL HOLDING SCREW CAN NO LONGER BE PUSHED THROUGH THE NAIL HOLDING BRACKET."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14487580 ↗
• MalfunctionOct 7, 2021Separation Failure; Misassembly by Users; Separation Failure; Misassembly by Users

  IT WAS REPORTED THE NAIL WAS ATTACHED TO THE HANDLE BACKWARDS AND WOULD NOT COME OFF. ADDITIONAL INFORMATION: THE PROCEDURE COULD BE COMPLETED SUCCESSFULLY USING FREEHAND TECHNIQUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12590476 ↗
• MalfunctionAug 10, 2021Material Fragmentation; Difficult to Insert; Device Difficult to Setup or Prepare; Material Fragmentation; Difficult to Insert; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE NAIL HOLDING SCREW (1806-0370) WOULD NOT PASS THROUGH THE TARGETER ATTACHMENT (1806-1002). THE SURGEON HAD TO SWITCH NAIL SYSTEMS AS THE CASE COULD NOT BE COMPLETED WITHOUT THESE INSTRUMENTS. THE SURGEON TRIED THE FIRST SCREW AND IT DIDN¿T PASS THROUGH. THE SURGEON TRIED THE SECOND WITH THE SAME OUT COME. THE SCREWS LOST SOME OF THE THREADS WHILE ATTEMPTING TO PASS THEM THROUGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12304005 ↗
• MalfunctionAug 10, 2021Material Fragmentation; Difficult to Insert; Device Difficult to Setup or Prepare; Material Fragmentation; Difficult to Insert; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE NAIL HOLDING SCREW (1806-0370) WOULD NOT PASS THROUGH THE TARGETER ATTACHMENT (1806-1002). THE SURGEON HAD TO SWITCH NAIL SYSTEMS AS THE CASE COULD NOT BE COMPLETED WITHOUT THESE INSTRUMENTS. THE SURGEON TRIED THE FIRST SCREW AND IT DIDN¿T PASS THROUGH. THE SURGEON TRIED THE SECOND WITH THE SAME OUT COME. THE SCREWS LOST SOME OF THE THREADS WHILE ATTEMPTING TO PASS THEM THROUGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12303950 ↗
• MalfunctionMay 18, 2021Separation Failure; Mechanical Jam; Separation Failure; Mechanical Jam

  THE CUSTOMER REPORTED THAT : "STRYKER TIBIA NAIL FIXATION SLEEVE STUCK IN THE TIBIA NAIL HOLDER (1806-1002 - N°KH171892) AND IN THE NAIL: IMPOSSIBLE TO UNSCREW THEM AND THEREFORE TO PLACE THE NAIL (1822-1034S - N°K03F75C) IN THE PATIENT, THEREFORE CHANGE THE SIZE OF THE NAIL AND PLACE A NAIL WITHOUT AN ANCILLARY. IN THE END, THERE IS NO CLINICAL IMPACT FOR THE PATIENT. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11841974 ↗
• MalfunctionDec 30, 2020Difficult or Delayed Separation; Difficult or Delayed Separation

  AS REPORTED: "T2 TIBIA NAIL UNABLE TO BE DISCONNECTED FROM NAIL ADAPTER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11098138 ↗
• MalfunctionDec 4, 2020Difficult or Delayed Separation; Difficult or Delayed Separation

  SALES REP REPORTED THAT: " THE FIXING SCREW HAS REMAINED STUCK IN THE NAIL HOLDER" SURGERY WAS COMPLETED SUCCESSFULLY "BY OPENING THE SECOND DEPOSIT AT THE ESTABLISHMENT." CLINICAL CONSEQUENCES FOR THE PATIENT: "NO, BECAUSE THE TEAM CHECKED THE ASSEMBLY OF THE DEVICES BEFORE WORKING ON THE PATIENT AND THAT BY CHANCE THE SECOND SET OF INSTRUMENTS IN STORAGE HAD NOT BEEN USED." DELAYED BY 15 MIN. ADDITIONAL MEDICAL INTERVENTION NECESSARY: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10946095 ↗
• MalfunctionSep 25, 2020Difficult or Delayed Separation; Difficult or Delayed Separation

  THE END USER HAS REPORTED: EVENT DESCRIPTION : IT¿S A NEW DEPOT FOR T2 TIBIA, ONLY USE ONCE. THE NAIL HOLDING SCREW FOR TIBIA (REF 1806-0370) GOT STUCK IN THE TARGETING DEVICE (REF 1806-1002). WITH GREAT DIFFICULTY WE WERE ABLE TO REMOVE IT TO USE THE SECOND NAIL HOLDING SCREW AND WE HAVE THE SAME PROBLEM¿ AND IMPOSSIBLE TO CONNECT THE NAIL TO THE TARGET DEVICE ¿ AND IMPOSSIBLE TO USE THE T2 TIBIA NAIL. THE SURGEON HAD TO USE AN IMPLANT FROM AN OTHER COMPANY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10586387 ↗
• MalfunctionSep 25, 2020Difficult or Delayed Separation; Difficult or Delayed Separation

  THE END USER HAS REPORTED: EVENT DESCRIPTION : IT¿S A NEW DEPOT FOR T2 TIBIA, ONLY USE ONCE. THE NAIL HOLDING SCREW FOR TIBIA (REF 1806-0370) GOT STUCK IN THE TARGETING DEVICE (REF 1806-1002). WITH GREAT DIFFICULTY WE WERE ABLE TO REMOVE IT TO USE THE SECOND NAIL HOLDING SCREW AND WE HAVE THE SAME PROBLEM¿ AND IMPOSSIBLE TO CONNECT THE NAIL TO THE TARGET DEVICE ¿ AND IMPOSSIBLE TO USE THE T2 TIBIA NAIL. THE SURGEON HAD TO USE AN IMPLANT FROM AN OTHER COMPANY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10586386 ↗
• InjuryJun 7, 2019Activation, Positioning or Separation Problem

  THE PHARMACIST FROM THE HOSPITAL REPORTED THE FOLLOWING EVENT : "PATIENT PAS, FEMALE, 23 YEARS OLD, 60 KG. WHEN USING THE NAIL, THE NAIL DOES NOT COME OFF THE NAIL HOLDER. THE PROBLEM HAD ALREADY OCCURRED, THE EQUIPMENT WAS EXCHANGED WITH THE LABORATORY AND THE PROBLEM RECURRED. LABORATORY NOTIFIED AND BROUGHT US A NEW NAIL HOLDER WITH LOCKING SCREWS. USE OF ANOTHER INSTRUMENT PANEL NEW INFORMATION RECEIVED ON (B)(6) 2019 INDICATED THAT THERE WAS AN IMPACT ON THE PATIENT, ESPECIALLY DURING THE FIRST PROCEDURE. AS A REMINDER, IT WAS AN OPEN LEG FRACTURE, BUT TOTALLY ACCESSIBLE TO A CENTRO-MEDULLARY NAILING. SURGEON APPROACHED AND DRILLED THE UPPER END OF THE TIBIA, HE MADE A COMPLETE BORE OF THE TIBIA (FOR NOTHING. FOR INFORMATION: RISK OF INCREASED FAT EMBOLISM DUE TO THE USE OF A SHEET), BEFORE HE REALIZED THAT THE NAIL INSTRUMENT WAS NOT WORKING AND THEREFORE CHANGE THE MEANS OF FIXATION (SO: EXTERNAL FIXATOR). THERE WAS A LOSS OF TIME OF ABOUT 30 MINUTES, THE TIME TO LOOK FOR OTHER BOXES, TO REALIZE THAT THEY WERE NOT WORKING EITHER, TO CALL LYON SOUTH TO "HELP US OUT", TO HAVE THE EXTERNAL FIXER BOX LOOKED FOR. DURING THE 1ST OPERATION, AFTER REMOVING THE INSTRUMENT SET FROM TH

  Patient problems: Discomfort; Myocardial Infarction

  MAUDE report 8680255 ↗
• InjuryJun 7, 2019Therapeutic or Diagnostic Output Failure

  THE PHARMACIST FROM THE HOSPITAL REPORTED THE FOLLOWING EVENT : "PATIENT PAS, FEMALE, 23 YEARS OLD, 60 KG. WHEN USING THE NAIL, THE NAIL DOES NOT COME OFF THE NAIL HOLDER. THE PROBLEM HAD ALREADY OCCURRED, THE EQUIPMENT WAS EXCHANGED WITH THE LABORATORY AND THE PROBLEM RECURRED. LABORATORY NOTIFIED AND BROUGHT US A NEW NAIL HOLDER WITH LOCKING SCREWS. USE OF ANOTHER INSTRUMENT PANEL NEW INFORMATION RECEIVED ON (B)(6) 2019 INDICATED THAT THERE WAS AN IMPACT ON THE PATIENT, ESPECIALLY DURING THE FIRST PROCEDURE. AS A REMINDER, IT WAS AN OPEN LEG FRACTURE, BUT TOTALLY ACCESSIBLE TO A CENTRO-MEDULLARY NAILING. SURGEON APPROACHED AND DRILLED THE UPPER END OF THE TIBIA, HE MADE A COMPLETE BORE OF THE TIBIA (FOR NOTHING. FOR INFORMATION: RISK OF INCREASED FAT EMBOLISM DUE TO THE USE OF A SHEET), BEFORE HE REALIZED THAT THE NAIL INSTRUMENT WAS NOT WORKING AND THEREFORE CHANGE THE MEANS OF FIXATION (SO: EXTERNAL FIXATOR). THERE WAS A LOSS OF TIME OF ABOUT 30 MINUTES, THE TIME TO LOOK FOR OTHER BOXES, TO REALIZE THAT THEY WERE NOT WORKING EITHER, TO CALL LYON SOUTH TO "HELP US OUT", TO HAVE THE EXTERNAL FIXER BOX LOOKED FOR. DURING THE 1ST OPERATION, AFTER REMOVING THE INSTRUMENT SET FROM TH

  Patient problems: Discomfort; Myocardial Infarction

  MAUDE report 8680254 ↗
• MalfunctionApr 4, 2019Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT, DURING A TIBIAL NAIL PROCEDURE, WHEN IT CAME TIME TO ATTACH THE NAIL TO THE HOLDING BOLT, THE THREADS INSIDE THE NAIL WOULD NOT ENGAGE WITH THE HOLDING BOLT. MULTIPLE ATTEMPTS WITH NO SUCCESS. A SECOND NAIL WAS OPENED AND THE NAIL SUCCESSFULLY ENGAGED WITH THE HOLDING BOLT. TWO MINUTE SURGICAL DELAY REPORTED. NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8483107 ↗
• MalfunctionDec 6, 2018Fitting Problem

  IN ORDER TO ATTACH THE NAIL TO THE NAIL HANDLE, TRIED TO INSERT A HOLDING SCREW FROM THE POST. THE SCREW DID NOT ENTER ALL THE WAY AND THE THREAD PART DID NOT REACH THE NAIL. THERE WAS ANOTHER SPARE SCREW, BUT IT COULD NOT ENTER INTO THE POST AGAIN. FORCED IT IN, BUT COULD NOT ATTACH THE NAIL TO THE HANDLE. SHAVED OFF BOTH THE HANDLE AND THE SCREW WITH RASP, AND MANAGED TO CONTINUE THE OPERATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8139888 ↗