T2 1806-4260Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 04546540196767), received between Jan 8, 2020 and Apr 7, 2026 — classified as 3 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Fracture” (22 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2026Fracture

  AS REPORTED: "DURING SURGERY TO INSERT A T2 ANKLE NAIL, A 4.2 MM DRILL BIT BROKE AT BOTH THE PROXIMAL AND DISTAL FIXATION SCREW INSERTION SITES AFTER COMING INTO CONTACT WITH THE NAIL. THIS RESULTED IN THE BREAKAGE OF TWO DRILL BITS. AS THE HOSPITAL HAD A GMMA4 FIXATION DRILL OF THE SAME DIAMETER IN STOCK, THIS WAS USED AS A SUBSTITUTE TO COMPLETE THE OPERATION.".

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24807306 ↗
• MalfunctionApr 1, 2026Fracture

  AS REPORTED: "WHEN A DRILL WAS USED TO INSERT A SCREW FROM THE POSTERIOR SIDE OF THE CALCANEUS, THE DRILL DID NOT PASS THROUGH THE NAIL HOLE AND INSTEAD CONTACTED THE FRONT OF THE NAIL. THE DRILL BROKE AND THE BROKEN PIECES REMAINED INSIDE THE CALCANEUS. AN ADDITIONAL SKIN CUT WAS REQUIRED TO REMOVE THE DRILL FROM THE BONE, WHICH EXTENDED THE SURGERY TIME."

  Patient problems: Perforation

  MAUDE report 24755385 ↗
• MalfunctionMar 6, 2026Failure to Align; Material Deformation; Mechanical Jam

  AS REPORTED: "DURING PROXIMAL TIBIAL DRILLING, THE MIS-DRILL WAS OCCURRED AND THE DRILL TIP BECAME STUCK IN THE HOLE. THE DRILL WAS CONTINUED TO BE ROTATED WHILE STUCK, RESULTING IN DAMAGE TO THE TIP."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24532803 ↗
• InjuryMay 6, 2025Failure to Align; Failure to Align

  AS REPORTED: "ANKLE NAIL WAS INTRODUCED. SCREWS WERE LOCKED. MOST DISTAL CALCANEAL SCREW TRAJECTORY WAS DRILLED WITH A 4.2MM DRILL, TROUGH THE TARGETING DEVICE. THE DRILL DIDN'T END UP IN THE HOLE BUT SCRATCHED THE NAIL ON THE SIDE. THE NAIL WAS REMOVED, TESTED AND RE-INSERTED. THE INCIDENT HAPPENED AGAIN. THIS WAS TRIED 3 TIMES. SURGERY WAS DELAYED BY 2 HOURS. A PLATE WAS USED TO FUSE THE ANKLE, WHICH LEAD TO EXTRA INCISION AND DUE TO THE PLATE, NO BONE GRAFT COULD BE USED, WHICH WAS PLANNED."

  Patient problems: Insufficient Information

  MAUDE report 21966995 ↗
• MalfunctionApr 22, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "WHEN DRILLING FOR INSERTION OF A PA SCREW INTO THE CALCANEUS, THE DRILL MISSED THE SCREW HOLE AND GRAZED THE NAIL. WHEN TRYING TO REMOVE THE DRILL WHILE TURNING, THE DRILL BIT BROKE OFF. WHEN DRILLING AGAIN WITH A SPARE DRILL, IT BROKE OFF IN THE SAME WAY".

  Patient problems: Insufficient Information

  MAUDE report 21883314 ↗
• MalfunctionApr 22, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "WHEN DRILLING FOR INSERTION OF A PA SCREW INTO THE CALCANEUS, THE DRILL MISSED THE SCREW HOLE AND GRAZED THE NAIL. WHEN TRYING TO REMOVE THE DRILL WHILE TURNING, THE DRILL BIT BROKE OFF. WHEN DRILLING AGAIN WITH A SPARE DRILL, IT BROKE OFF IN THE SAME WAY".

  Patient problems: Insufficient Information

  MAUDE report 21883053 ↗
• MalfunctionFeb 26, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "THE DRILL MADE CONTACT WITH THE NAIL DURING DRILLING AND BROKE OFF."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21470245 ↗
• InjuryDec 12, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT: "DURING DRILLING OF THE DISTAL LOCKING OF A GAMMA NAIL, THE DRILL BIT BROKE IN 2 IN THE PATIENT. THE DISTAL FRAGMENT, MEASURING APPROXIMATELY 3CM, REMAINED IN THE PATIENT, AS EXTRACTION WAS IMPOSSIBLE. THUS, THE DISTAL LOCKING IS IMPOSSIBLE." ON (B)(6) 2024 - ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER: THE DRILL GUIDE (TARGET DEVICE) OF THE STRYKER ANCILLARY IS USED TO GUIDE THE DRILL FOR DISTAL SCREW PLACEMENT. BEFORE PLACING THE NAIL IN THE PATIENT'S FEMUR, WE SYSTEMATICALLY CHECK THAT THE ANCILLARY IS FUNCTIONING CORRECTLY, WITH THE NAIL IN PLACE ON THE ANCILLARY. YES, THEORETICALLY, THE GUIDE POSITIONS THE DRILL BIT OPPOSITE THE NAIL'S LOCKING HOLE, BUT IN THIS CASE THAT WASN'T THE CASE, AS THE DRILL BIT PIERCED THE FIRST CORTEX OF THE FEMUR, THEN BROKE WHEN PERFORATING THE SECOND. IT MUST HAVE RUBBED ABNORMALLY ON THE NAIL'S LOCKING HOLE, RESULTING IN EXCESSIVE STRESS AND CONSEQUENT BREAKAGE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20921056 ↗
• InjuryFeb 26, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "AFTER COMPRESSION OF BOTH THE TALOFEMORAL AND TALOCALCANEAL JOINTS, A DRILL FRACTURE OCCURRED WHEN DRILLING INTO THE CALCANEUS FROM THE LATERAL SIDE. THEY GAVE UP ON THE HOLE AND MOVED ON TO THE POSTERIOR CALCANEAL SCREW INSERTION TECHNIQUE. AFTER DRILLING AND MEASURING WITH A DEPTH GAUGE, THE SCREW WAS INSERTED, BUT IT WAS FOUND THAT THE SCREW HAD OB'D. THE SCREW WAS REMOVED AND THE DRILL WAS BROKEN WHEN DRILLING AGAIN. TWO SCREWS THAT COULD BE INSERTED INTO THE CALCANEUS THROUGH THE NAIL WERE NOT INSERTED. INSTEAD, TWO SCREWS WERE INSERTED BY FREEHAND DRILLING FROM OUTSIDE THE NAIL. NO BROKEN PIECES OF THE DRILL WERE LEFT BEHIND IN THE BODY." . THIS RESULTED IN A 30 MINUTE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16441208 ↗
• MalfunctionFeb 26, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "AFTER COMPRESSION OF BOTH THE TALOFEMORAL AND TALOCALCANEAL JOINTS, A DRILL FRACTURE OCCURRED WHEN DRILLING INTO THE CALCANEUS FROM THE LATERAL SIDE. THEY GAVE UP ON THE HOLE AND MOVED ON TO THE POSTERIOR CALCANEAL SCREW INSERTION TECHNIQUE. AFTER DRILLING AND MEASURING WITH A DEPTH GAUGE, THE SCREW WAS INSERTED, BUT IT WAS FOUND THAT THE SCREW HAD OB'D. THE SCREW WAS REMOVED AND THE DRILL WAS BROKEN WHEN DRILLING AGAIN. TWO SCREWS THAT COULD BE INSERTED INTO THE CALCANEUS THROUGH THE NAIL WERE NOT INSERTED. INSTEAD, TWO SCREWS WERE INSERTED BY FREEHAND DRILLING FROM OUTSIDE THE NAIL. NO BROKEN PIECES OF THE DRILL WERE LEFT BEHIND IN THE BODY." THIS RESULTED IN A 30 MINUTE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16441193 ↗
• MalfunctionJan 11, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "DURING A ANKLE ARTHRODESIS T2 NAIL, DRILL BIT BROKE OFF INSIDE THE PATIENT AND COULD NOT BE REMOVED. THE SURGERY DID NOT CAUSE ANY HARM TO THE PATIENT, BUT IT WAS NOT POSSIBLE TO INSERT THE POSTERO-ANTERIOR SCREW IN THE CALCANEUS. THERE WAS A DELAY OF ABOUT 20 MINUTES TRYING TO GET THE BROKEN PIECE OUT".

  Patient problems: Foreign Body In Patient

  MAUDE report 16141784 ↗
• MalfunctionApr 20, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A MEDICAL PROCEDURE, 2 CUTTERS OF 4.2 LENGTH 340 BROKE.

  Patient problems: Insufficient Information

  MAUDE report 14161130 ↗
• MalfunctionApr 20, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A MEDICAL PROCEDURE, 2 CUTTERS OF 4.2 LENGTH 340 BROKE.

  Patient problems: Insufficient Information

  MAUDE report 14161129 ↗
• MalfunctionApr 7, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "TIP OF DRILL BIT BROKEN DURING PROCEDURE."

  Patient problems: Insufficient Information

  MAUDE report 14043797 ↗
• MalfunctionNov 12, 2021Fracture; Fracture

  CUSTOMER REPORTED THE FOLLOWING ISSUE: "DURING PROXIMAL LOCKING, THE DIAM 3.2 LONG 340 DRILL BIT OF THE T2 FEMUR NAIL ANCILLARY BROKE. THE END OF THE DRILL BIT THEREFORE REMAINED IN THE LESSER TROCHANTER. NO POSSIBILITY TO REMOVE IT, IT REPLACED THE DYNAMIC SCREW. HUMAN CONSEQUENCES: THE BROKEN DRILL BIT WAS LEFT IN THE BONE. A PRIORI, TO DATE, NO IMPACT ON THE PATIENT'S CURRENT CONDITION (THE INCIDENT TOOK PLACE ON (B)(6) AT 1AM, AND THE BREAK WAS CLEAN). THIS INCIDENT DID NOT REQUIRE ANY PARTICULAR FOLLOW-UP OF THE PATIENT. IT WAS NOT POSSIBLE TO RECOVER THE REST OF THE DILL BIT AS IT WAS DISPOSED OF IN A NEEDLE CONTAINER".

  Patient problems: Foreign Body In Patient

  MAUDE report 12802287 ↗
• MalfunctionSep 2, 2021Fracture; Fracture

  THE CUSTOMER REPORTED THAT: "WE HAD A PROBLEM DURING AN INTERVENTION." ON 08/09/2021 THE CUSTOMER ADDED THAT: "DURING A SURGERY USING THE "FEMUR NAIL" ANCILLARY, THE LOCKING BIT BROKE OFF IN THE BONE DURING DISTAL LOCKING. THE BROKEN DRILL BIT WAS REMOVED WITHOUT DIFFICULTY. NO CLINICAL CONSEQUENCES TO DATE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12413916 ↗
• MalfunctionJan 13, 2021Fracture; Fracture

  IT WAS REPORTED VIA MEDWATCH #: (B)(4): "THE DRILL BROKE OFF IN THE PATIENT'S FEMUR." UPDATE 30/DEC/2020 : FROM OP REPORT: ¿THE LATERAL IMAGE APPEARED TO SHOW THAT THE MOST DISTAL SCREW WAS NOT WITHIN THE NAIL. THIS WAS REMOVED. THE END CAP WAS ALSO REMOVED AND THE JOG WAS REPLACED. THE MOST DISTAL SCREW WAS RE-DRILLED. HOWEVER, THIS MET WITH METALLIC RESISTANCE AND WHEN THE DRILL WAS WITHDRAWN, IT APPEARED THAT THE TIP OF THE DRILL HAD BROKEN OFF. FLUOROSCOPIC IMAGES SHOWED THE DRILL TIP EMBEDDED WITHIN THE BONE. A NEW DRILL WAS USED, WHICH ALSO MET WITH METALLIC RESISTANCE. IT APPEARED THAT THE SCREW WAS HITTING ONE OF THE POSTS FROM THE FEMORAL COMPONENT. THE DECISION WAS MADE NOT TO PLACE THE MOST DISTAL SCREW. A MORE PROXIMAL TRANSVERSE SCREW WAS PLACED THROUGH THE JIG. FINAL FLUOROSCOPIC IMAGES SHOWED GOOD FEMORAL ALIGNMENT AND THE DRILL TIP WAS CONTAINED ENTIRELY WITHIN THE BONE.¿ COMPLICATIONS: ¿BROKEN DRILL BIT WITHIN THE DISTAL FEMUR.¿

  Patient problems: Foreign Body In Patient

  MAUDE report 11168032 ↗
• MalfunctionJan 6, 2021Fracture; Fracture

  THE CUSTOMER REPORTED TO OUR TECHNICAL SERVICE THAT : "IN EARLY AUGUST, ONE OF OUR OPERATING ROOM TEAMS HAD A PROBLEM WITH A DRILL BIT FOR NAILING, REF. 1806-4260, SN (B)(6). WHEN THE DRILL BIT WAS USED TO MAKE THE HOLE FOR THE FEMORAL NAIL, IT BROKE DURING INSERTION AND A PIECE REMAINED IN THE PATIENT'S BONE. IN DIRECT ACTION, OUR BIOMEDICAL WORKSHOP PROCEEDED TO ACQUIRE A NEW DRILL BIT. THE BROKEN DRILL BIT IS IN MY POSSESSION IF IT IS NECESSARY TO RECOVER IT FOR EXPERTISE."

  Patient problems: Foreign Body In Patient

  MAUDE report 11127659 ↗
• MalfunctionApr 3, 2020Fracture; Fracture

  PHARMACIST RESIDENT REPORTED THAT: " WHILE DRILLING THE FEMUR, THE TIP OF THE DRILL BIT BROKE OFF AND REMAINED IN THE FEMUR. CLINICAL CONSEQUENCES: INCREASED OPERATING TIME (TIME TO REMOVE THE TIP) WITH RISK WITH A PATIENT WITH A COMPLICATED FEMUR FRACTURE. THE SURGEON WAS ABLE TO REMOVE THE TIP USING A NEEDLE HOLDER. THE DM WAS RETAINED AND IS AVAILABLE FOR EXPERT EVALUATION." 10 MINUTE DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9922645 ↗
• MalfunctionMar 27, 2020Fracture; Fracture

  PHARMACIST, REPORTED BY PHONE: "THE DRILL BROKE DURING THE PROCEDURE. THERE WAS A PROCEDURE DELAY. NO FURTHER INFORMATION AVAILABLE, WE WILL PROVIDE YOU MORE DETAILS". ADDITIONALLY REPORTED BY PHARMACIST: "I CONFIRM MATERIOVIGILANCE NOTIFICATION ON PRODUCT 18064260 LOT K227443. THE EVENT HAPPENED DURING PROCEDURE, WHEN INSERTING THE DRILL BIT INTO THE LOCKING HOLE OF THE NAIL. THERE WERE NO CONSEQUENCES ON THE PROCEDURE TIME (REPLACEMENT OF THE DRILL WITH ANOTHER AVAILABLE DRILL) OR ON THE PATIENT (EASY REMOVAL OF THE 2 PIECES). NO MEDICAL INTERVENTION WAS NECESSARY."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9891479 ↗
• MalfunctionJan 13, 2020Fracture; Fracture

  DRILLS BROKE DURING MEDICAL PROCEDURE AND REMAIN IN THE PATIENTS BONE.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 9584525 ↗
• MalfunctionJan 13, 2020Fracture; Fracture

  DRILLS BROKE DURING MEDICAL PROCEDURE AND REMAIN IN THE PATIENTS BONE.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 9584524 ↗
• MalfunctionJan 8, 2020Fracture; Fracture

  AS REPORTED: "DURING THE FEMUR OSTEOSYNTHESIS PROCEDURE, THE DOCTOR TRIES TO PERFORM THE PERFORATIONS FOR THE PROXIMAL LOCKING HOLES AND THE DRILL BIT IS FRACTURED, ANOTHER ONE OF THE SAME REFERENCE IS USED WHICH ALSO FRACTURES."

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 9567104 ↗
• MalfunctionJan 8, 2020Fracture; Fracture

  AS REPORTED: "DURING THE FEMUR OSTEOSYNTHESIS PROCEDURE, THE DOCTOR TRIES TO PERFORM THE PERFORATIONS FOR THE PROXIMAL LOCKING HOLES AND THE DRILL BIT IS FRACTURED, ANOTHER ONE OF THE SAME REFERENCE IS USED WHICH ALSO FRACTURES."

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 9567101 ↗