NA 1806-0125Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540196040), received between May 25, 2018 and Jul 12, 2024 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 12, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, ON FRIDAY,31-MAY-2024, THE SURGEON FROM THE ARRIXACA HOSPITAL PROCEEDS TO PERFORM TIBIA FRACTURE SURGERY WITH A T2 TIBIA INTRAMEDULLARY NAIL. WHEN INSERTING THE FRACTURE REDUCTION PIECE, IT BREAKS, LEAVING PART OF IT INSIDE THE PATIENT'S CANAL. GIVEN THE IMPOSSIBILITY OF EXTRACTING IT WITH THE MATERIAL THEY HAD, THEY COMPLETED THE SURGERY, POSTPONING IT TO WEDNESDAY, (B)(6) 2024, TO PROCEED WITH THE EXTRACTION OF THE BROKEN MATERIAL AND THE INTRODUCTION OF AN INTRAMEDULLARY NAIL. ON WEDNESDAY THE SURGERY WAS PERFORMED SATISFACTORILY, BEING ABLE TO EXTRACT THE BROKEN PIECE WITH THE MATERIAL SENT FOR THE OCCASION (STRYKER DIFFICULT EXTRACTION KIT).

  Patient problems: Foreign Body In Patient

  MAUDE report 19728626 ↗
• MalfunctionJul 16, 2020Fracture; Fracture

  CUSTOMER REPORTED THAT : "PEROPERATIVE, DURING FEMORAL NAILING WITH THE FEMORAL NAILING SYSTEM 12, THE DISTAL PART OF THE REDUCTION NAIL BROKE AT THE JUNCTION WITH THE THREAD IN THE MEDULLARY SHAFT. THE EXTRACTION ROD (1806-0110) COUPLED TO THE REDUCTION INSTRUMENT (1806-0125) CAN BE USED AS A REDUCTION INSTRUMENT SET. THE CRUTCHED PART OF THE REDUCTION NAIL BREAKS WITHOUT EXPLANATION AT THE JUNCTION WITH THE SCREW THREAD: IT IS NECESSARY TO APPROACH TO REMOVE IT FROM THE FEMORAL SHAFT: LATERAL APPROACH TO EXPOSE THE FRACTURE, REDUCTION AFTER DESINCARCERATION AND INSERTION OF THE GUIDE PIN.". MEASURES TAKEN : TECHNIQUE MODIFIED, PLACEMENT OF AN S.2 FEMUR NAIL LENGTH 380, DIAMETER 10 DISTAL AND PROXIMAL LOCKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10286363 ↗
• MalfunctionMar 18, 2019Break; Use of Device Problem

  THE STRYKER REP REPORTED THEY WERE SUPPORTING A CASE WHERE THE SURGEON WAS USING THE UNIVERSAL ROD AND REDUCTION. THE SURGEON APPLIED A LOT OF FORCE THROUGH A HAMMER WHICH CAUSED THE DEVICE TO BREAK. THE SPOON PART OF THE INSTRUMENTS BROKE AWAY FROM THE ROD, LEAVING IT IN THE FEMORAL CANAL. THE SPOON WAS RETRIEVED BY OPENING THE FEMUR AT THE FRACTURE SITE, AND THE REP REPORTED THAT THIS WOULD OF HAD TO BE CARRIED OUT TO REDUCE THE FRACTURE ANYWAY. SLIGHT DELAY, NO MORE THAN 5 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8429021 ↗
• InjuryDec 17, 2018Break

  THE PHARMACIST AT THE HOSPITAL REPORTED THE FOLLOWING EVENT : "I WOULD LIKE TO CONTACT YOU FOR A DECLARATION OF MATERIOVIGILANCE ON A GUIDE FOR NAIL GUIDE T2 (RESTÉRILISABLE MATERIAL REF 1806-0125K134075 / 1806-0110K537887). DURING AN INTERVENTION ON (B)(6) 2018, THE SCREW THREAD CONNECTING THE TWO PARTS OF THE GUIDE BROKE IN THE FEMORAL SHAFT DURING THE ATTEMPT TO REDUCE A FEMORAL FRACTURE, RESULTING IN AN ADDITIONAL INCISION ON THE LEG TO BE ABLE TO ACCESS THE LOWER END OF THE INSTRUMENT IN ORDER TO BE ABLE TO REMOVE IT. AN ADDITIONAL INCISION HAD TO BE MADE ON THE LEG TO GAIN ACCESS TO THE LOWER END OF THE INSTRUMENT IN ORDER TO REMOVE IT.

  Patient problems: Foreign Body In Patient

  MAUDE report 8171154 ↗
• MalfunctionMay 25, 2018Fracture

  PRIMARY PROCEDURE, RIGHT DISTAL TIBIAL NAIL IMPLANT ON A RIGHT TOTAL KNEE PATIENT. IT WAS REPORTED THAT PATIENT HAD A DISTAL ANTERIOR FRACTURE OF THE RIGHT TIBIA (CAUSE OF FRACTURE UNKNOWN), AND THE SURGEON WAS PERFORMING A REDUCTION. AS REPORTED, SURGEON USED "UNIVERSAL ROD AND FINGER TOOL (AKA REDUCTION SPOON). RINGED UP TO 9/12 IN THE TIBIA. WHEN PUTTING FINGER TOOL DISTALLY TO GET REDUCTION, SOMETHING DISLODGED. SURGEON USED SLOTTED MALLET BUT WAS NOT GETTING THE DEVICE DOWN. WHEN PULLING THE DEVICE BACK OUT A PIECE OF THE FINGER TOOL BROKE OFF 10MM UP FROM THE THREADED PORTION (THREADED PORTION REMAINED IN UNIVERSAL ROD), AND THE REMAINDER OF THE FINGER TOOL REMAINED IN THE TIBIA". SURGEON REMOVED THE REMAINDER OF THE DEVICE BY REMOVING IT THROUGH THE FRACTURE SITE DISTALLY. SURGICAL DELAY OF 30-45 MINUTES WAS REPORTED WITH A TOTAL TOURNIQUET TIME OF 2 TO 2 1/2 HOURS. THE SURGEON TOLD THE REP HE WANTS TO KNOW WHY THIS HAPPENED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7546120 ↗