T2 1822-0936SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540197795), received between Oct 26, 2018 and Feb 12, 2020 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2020Difficult or Delayed Separation; Difficult or Delayed Separation

  CUSTOMER REPORTED THAT : "PROCEDURE: DOUBLE TIBIA-FIBULA FRACTURE. PLACEMENT OF A TIBIAL NAIL WITH A HANDPIECE. AT THE END OF THE OPERATION, DURING THE REMOVAL OF THE HANDPIECE, THE TIBIAL NAIL REMAINED STUCK ON THE NAIL HOLDER OF THE ANCILLARY. AFTER MULTIPLE ATTEMPTS, IT WAS IMPOSSIBLE TO DETACH THE NAIL FROM THE ANCILLARY. THE SURGEON WAS FORCED TO EXPLANT THE NAIL AND SCREWS PUT IN PLACE AND PERFORM A NEW BORE. CHANGE OF NAIL WITH OBLIGATION TO DRIVE A BIGGER NAIL BECAUSE NO OTHER NAILS OF THE SAME SIZE IN STOCK." DELAY : 1H. OPENING OF A NEW ANCILLARY INSTRUMENT SET AND PLACEMENT OF A BIGGER NAIL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9703382 ↗
• MalfunctionJan 29, 2020Difficult to Remove; Mechanical Jam; Difficult to Remove; Mechanical Jam

  IT WAS REPORTED THAT THE "TIBIAL ALIGNMENT GUIDE IN QUESTION EXHIBITED GREAT DIFFICULTY IN ATTACHING TO THE NAIL (VIA THE NAIL HOLDING BOLTS). SURGEON TRIED FIRST BOLT, IT WOULD NOT ATTACH AND NEARLY GOT PERMANENTLY STUCK INSIDE THE ALIGNMENT HANDLE. 2ND BOLT WAS FIRMLY ATTACHED TO THE NAIL HOWEVER COULD NOT BE SUBSEQUENTLY DISASSEMBLED." SURGICAL DELAY OF 30-35 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9644228 ↗
• MalfunctionMay 20, 2019Difficult to Remove

  THE FOLLOWING EVENT WAS REPORTED TO ANSM BY THE DOCTOR: " 17-YEAR-OLD PATIENT, MANAGED FOR OSTEOSYNTHESIS BY CENTROMEDULLARY NAILING OF THE RIGHT TIBIA. DRILLING OF THE TIBIA AND INSERTION OF THE GUIDE ROD CENTERED IN THE FRONT AND PROFILE PIN, THEN IMPOSSIBILITY TO BRING OUT THE GUIDE ROD OF THE NAIL. " REMOVE THE NAIL WITH THE GUIDE ROD AND INSTALL A NEW NAIL. UNKNOWN AMOUNT OF EXTENSION OF THE SURGICAL PROCEDURE WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8625601 ↗
• InjuryJan 29, 2019Break; Fracture; Fracture

  REP WAS INFORMED ABOUT CASE: BROKEN T2 TIBIA ON (B)(6) 2019 AFTER PLACEMENT ON (B)(6) 2018. THE PATIENT HAS RECEIVED THE T2 TIBIA 9MM PEN AT THE (B)(6) AND YESTERDAY WAS URGENTLY OPERATED AT THE (B)(6) IN (B)(6) AND THE NAIL WAS REMOVED. REP CONTACTED WITH TWO TRAUMA SURGEONS WHO HAVE BOTH BEEN SURPRISED ABOUT THE BREAKING OF THE PEN. DATA IS NOW BEING REQUESTED AND THE NAIL IS IN POSSESSION OF SURGEON.

  Patient problems: No Code Available

  MAUDE report 8287408 ↗
• InjuryOct 26, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT TIBIA WAS REVISED DUE TO SUSPICION OF INFECTION AFTER PATIENT PRESENTED WITH PUS AT THE IMPLANT SITE. REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND ADDITIONAL INFORMATION ARE NOT AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: Unspecified Infection

  MAUDE report 8010638 ↗