NA 1806-4260SRecalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 04546540196774), received between May 2, 2018 and Aug 5, 2026 — classified as 8 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Fracture” (41 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 52 reports, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2026Fracture

  It was reported that, it involved a 4.2mm 340mm (18064260s) drill during a SCN nail. The end snapped in the patient and was irretrievable.

  Patient problems: Foreign Body In Patient

  MAUDE report 50146844 ↗
• MalfunctionFeb 6, 2026Failure to Align

  AS REPORTED: "WE HAVE HAD A CASE TODAY WHERE THE DRILL AND SCREW MISSED THE POSTERIOR LOCKING HOLE OF THE NAIL THROUGH THE JIG. THE JIG WAS ALSO STIFF TO LOCK INTO THE POSTERIOR LOCKING HOLE." FURTHER INFORMATION FROM REP RECEIVED: "THE SURGEON REDRILLED FOR TALUS SCREW AND SCREW THEN WENT IN FINE. SURGEON DID NOT USE THE POSTERIOR SCREW AS IT KEPT MISSING THE HOLE IN THE NAIL THROUGH THE JIG. THE JIG WAS STIFF BUT IT WOULD STILL LOCKING INTO POSITION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24283809 ↗
• InjuryJan 6, 2026Fracture

  AS REPORTED BY SALES REP: "DRILL BIT BROKEN WHILST IN PATIENT." CUSTOMER REPORT: "IT WAS A 4.2X 340 (REF 180604260S LOT K1278DA) IT SNAPPED IN HOLE 3 DURING A SUPRACONDYLAR NAIL. THE SCRUB NURSE HAS CONFIRMED THAT THEY TESTED EACH HOLE ON THE JIG WITH TROCAR AND DRILL BEFORE PUTTING THE NAIL INSIDE THE PATIENT. THE SURGEON DIDN'T APPLY MUCH PRESSURE WHEN DRILLING THE HOLE EITHER. WE WERE UNABLE TO REMOVED THE SNAPPED DRILL FROM THE PATIENT."

  Patient problems: Foreign Body In Patient

  MAUDE report 23975784 ↗
• MalfunctionDec 26, 2025Fracture; Fracture

  AS REPORTED: "DRILL BIT BROKE DURING USAGE".

  Patient problems: Insufficient Information

  MAUDE report 23896433 ↗
• InjuryDec 17, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING TODAY¿S SURGERY, A PRIMARY SURGERY AFTER EXTERNAL FIXATEUR A BREAKAGE OF THE DRILL 18064260S D4.2MM X 340MM, AO COLOR CODE GREEN, OCCURRED DUE TO APPLICATION DIFFICULTIES. AS A RESULT, ONE TIP BROKE OFF. THIS HAPPENED DURING THE STEP OF DRILLING THE POSTERIOR CALCANEAL SCREW IN THE PROCEDURE. THERE WAS NO HARD NO REPORTED. THERE WAS NO SURGICAL DELAY, MEDICAL INTERVENTION REPORTED AND THE SURGERY WAS REPORTED TO HAVE BEEN COMPLETED SUCCESSFUL. THE PRODUCT FRESH OUT OF BOX, NOT RE-STERILIZED. THE TIP OF THE DRILL REMAINED IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23827937 ↗
• InjuryMay 15, 2025Break; Fracture; Break; Fracture

  THE CUSTOMER REPORTED THAT: "WHEN USED DURING SURGERY, THE DRILL BROKE (APPROX. 2.5CM) AND THE TIP REMAINED IN THE PATIENT. IMPOSSIBLE TO REMOVE. NO CONSEQUENCES"

  Patient problems: Foreign Body In Patient

  MAUDE report 22028418 ↗
• MalfunctionJan 16, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE DOCTOR WAS USING THE RETROGRADE JIG TO PUT IN AN OBLIQUE SCREW, AVOIDING CANNULATED SCREWS, THE JIG MISSED AND THE DRILL BROKE. THE BROKEN DRILL TRIP WAS LEFT IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21169649 ↗
• MalfunctionAug 22, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, DEBRIS WAS LEFT IN THE PATIENT AFTER THREE DRILL BITS BROKE. HOWEVER, IT IS UNCLEAR HOW MANY FRAGMENTS, IF ANY, REMAINED IN THE PATIENT, AS THIS INFORMATION WAS NOT PROVIDED BY THE HOSPITAL STAFF. THE PROCEDURE TOOK LONGER THAN ANTICIPATED, LASTING 4-5 HOURS. THE SURGERY WAS A REVISION FOR A FAILED ANKLE FUSION. THERE ARE NO X-RAYS AVAILABLE AT THIS TIME. ALL BROKEN DRILL BITS WERE DISCARDED AFTER THE SURGERY, SO NO ITEMS ARE AVAILABLE FOR RETURN OR ANALYSIS. THERE ARE NO KNOWN PATIENT COMPLICATIONS OR ADVERSE CONSEQUENCES DUE TO THE DELAY. IT IS ALSO UNKNOWN IF THE REVISED IMPLANTS WERE STRYKER DEVICES.

  Patient problems: Foreign Body In Patient

  MAUDE report 20023816 ↗
• MalfunctionAug 21, 2024Break; Fracture; Break; Fracture

  DURING A SURGERY, IT WAS REPORTED THAT DEBRIS WAS LEFT IN THE PATIENT. THREE DRILL BITS BROKE DURING THE PROCEDURE, BUT IT IS UNCLEAR WHICH OR HOW MANY FRAGMENTS REMAINED IN THE PATIENT, AS THE HOSPITAL STAFF DID NOT PROVIDE THIS INFORMATION. THE PROCEDURE ALSO TOOK LONGER THAN EXPECTED, 4-5 HOURS.

  Patient problems: Foreign Body In Patient

  MAUDE report 20022151 ↗
• InjuryAug 12, 2024Break; Fracture; Break; Fracture

  AS REPORTED : ''18-YEAR-OLD PATIENT ADMITTED TO THE EMERGENCY ROOM FOLLOWING A HIGH-KINETIC"AVP" FROM HIS SCOOTER WITHOUT A HELMET. DURING THE OPERATION, A T2 FEMORAL NAIL WAS INSERTED USING A NAIL-HOLDER FROM A DIE THROWER, WHICH MALFUNCTIONED WHEN THE DRILL BIT WAS INSERTED IN ORDER TO FIT THE PROXIMAL SYNCHRO LIST. THIS WAS NOT IN FRONT OF THE HOLE. WHEN INSERTING THE NAIL, THE NAIL-HOLDER SHIFTED. AFTER SEVERAL ATTEMPTS AT INSERTION, THE BIT BROKE.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19961608 ↗
• MalfunctionApr 29, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "DOCTOR PERFORMING A T2 AAN ON PATIENT; TWO OF THE 4.2X340 DRILL CUTTING PORTIONS BROKE OFF INSIDE THE PATIENT. THE DRILL POSSIBLY CAME IN CONTACT WITH THE NAIL ITSELF OR THE CANNULA WHILE BEING USED. ONE DRILL WAS REMOVED AND THE SECOND ONE WAS LEFT IN PATIENT"

  Patient problems: Foreign Body In Patient

  MAUDE report 19201496 ↗
• MalfunctionApr 29, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "DOCTOR PERFORMING A T2 AAN ON PATIENT; TWO OF THE 4.2X340 DRILL CUTTING PORTIONS BROKE OFF INSIDE THE PATIENT. THE DRILL POSSIBLY CAME IN CONTACT WITH THE NAIL ITSELF OR THE CANNULA WHILE BEING USED. ONE DRILL WAS REMOVED AND THE SECOND ONE WAS LEFT IN PATIENT"

  Patient problems: Foreign Body In Patient

  MAUDE report 19201491 ↗
• MalfunctionApr 22, 2024Break; Fracture; Break; Fracture

  THE CUSTOMER REPORTED THAT "42-YEAR-OLD POLYTRAUMATIZED PATIENT, VICTIM OF A ROAD ACCIDENT ON (B)(6) 2024, TREATED FOR OSTEOSYNTHESIS OF THE RIGHT FEMUR BY CLOSED-FOCUS CENTROMEDULLARY NAILING; DURING THE OPERATION, THE DRILL BIT BROKE. AFTER CHECKING WITH THE IMAGE INTENSIFIER, THE TIP OF THE BROKEN DRILL BIT COULD BE LOCATED AND REMOVED FROM THE PATIENT IN ITS ENTIRETY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19159498 ↗
• MalfunctionJan 25, 2024Break; Fracture; Break; Fracture

  DURING SURGERY THE DRILL BIT BROKE, LEAVING A PART IN THE PATIENT'S BONE. THE DECISION WAS MADE AT THE TIME, TO LEAVE THE PART IN SITU.

  Patient problems: Foreign Body In Patient

  MAUDE report 18580217 ↗
• InjuryJan 25, 2024Break; Fracture; Migration; Break; Fracture; Migration

  DURING SURGERY ON (B)(6), THE DRILL BIT BROKE AND IT WAS DECIDED TO LEAVE THE PART IN SITU. HOWEVER, IT HAS SINCE MOVED AND AS SUCH THE PATIENT HAD FURTHER SURGERY TO REMOVE THE PART.

  Patient problems: Foreign Body In Patient

  MAUDE report 18580216 ↗
• MalfunctionJan 2, 2024Break; Fracture; Break; Fracture

  THE DRILL BROKE WHILST DRILLING THE POSTERIOR SCREW ON THE CALCANEUS. A REPLACEMENT WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18425488 ↗
• MalfunctionJul 28, 2023Break; Fracture; Break; Fracture

  THE CUSTOMER REPORTED THAT "USE THE 4.2 X 340MM DRILL BIT TO HOLE TO PREPARE FOR INSERTION OF THE LOCKING SCREW 5MM LOCKING SCREW. THE DRILL BIT BROKE, A SECOND ONE WAS USED AND AGAIN BROKE, THE PIECES WERE PIECES WERE RECOVERED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17414199 ↗
• MalfunctionJul 28, 2023Break; Fracture; Break; Fracture

  THE CUSTOMER REPORTED THAT "USE THE 4.2 X 340MM DRILL BIT TO HOLE TO PREPARE FOR INSERTION OF THE LOCKING SCREW 5MM LOCKING SCREW. THE DRILL BIT BROKE, A SECOND ONE WAS USED AND AGAIN BROKE, THE PIECES WERE PIECES WERE RECOVERED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17414073 ↗
• MalfunctionMay 25, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED BY THE CUSTOMER THAT "PATIENT¿S ARTHRODESIS OF THE ANKLE SURGERY, THE DRILL BIT BROKE. SURGEON DETERMINED IT WAS SAFE TO LEAVE THE BROKEN BIT IN PLACE. (NO INJURY TO THIS PATIENT.)"

  Patient problems: Foreign Body In Patient

  MAUDE report 17001761 ↗
• MalfunctionApr 19, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "DURING PLACEMENT OF OBLIQUE DISTAL LOCKING SCREW THE DRILL BIT WAS DAMAGED AND BROKE INSIDE THE NAIL. THE DRILL BIT WAS DEEP WITHIN THE BONE AND STABLE. DECISION WAS MADE TO RETAIN THE DRILL BIT WITHIN THE INTRAMEDULLARY CANAL AS IT WAS STABLE AND PROVIDING FIXATION ALONG WITH 3 OTHER SCREWS".

  Patient problems: Foreign Body In Patient

  MAUDE report 16773664 ↗
• MalfunctionMar 27, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "4.2MM DRILL BIT BROKE OFF IN BONE". ADDITIONALLY IT WAS REPORTED THAT "ALL DEBRIS WAS REMOVED FROM THE SURGICAL FIELD/PATIENT AND THERE WAS A 90 MINUTE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16622967 ↗
• MalfunctionOct 28, 2022Break; Fracture; Break; Fracture

  THE CUSTOMER REPORTED THAT "DURING FEMORAL NAILING THE DRILL BIT REFERENCE 1806-4260S LOT KODAACB EXPIRY DATE 30-JUN-2027, BROKE IN THE PATIENT. REMOVAL OF THE BROKEN TIP AND CHANGE OF THE DRILL BIT .THERE WERE NO CONSEQUENCES FOR THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15690904 ↗
• MalfunctionAug 5, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE DRILL BIT BROKE DURING SURGERY. NO PARTS FELL INTO THE PATIENT OR SURGICAL SITE. SURGERY SUCCESSFUL AS ANOTHER SET WAS OPENED TO CONTINUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15174074 ↗
• MalfunctionJul 14, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT 2 DRILLS BROKE DURING OPERATION. THE BROKEN-OFF DRILLS WERE THEN PIERCED AND REMOVED CONTRALATERALLY. THE PROCEDURE WAS DELAYED BY 15 MIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15021969 ↗
• MalfunctionJul 14, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT 2 DRILLS BROKE DURING OPERATION. THE BROKEN-OFF DRILLS WERE THEN PIERCED AND REMOVED CONTRALATERALLY. THE PROCEDURE WAS DELAYED BY 15 MIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15020943 ↗