AXSOS 705025Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 07613327083422), received between Sep 28, 2016 and Aug 5, 2026 — classified as 5 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Fracture” (19 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.

• InjuryAug 5, 2026Fracture

  It was reported by the customer that the small end of the 2.5 mm Stryker Axsos drill bit broke while in use, leaving a fragment embedded in the patient's bone. The retained piece could not be removed. The surgeon is aware of the retained fragment. No patient harm was reported, no symptoms or adverse effects, and no additional treatment was required.

  Patient problems: Foreign Body In Patient

  MAUDE report 50146840 ↗
• MalfunctionAug 4, 2026Fracture

  Patient problems: Insufficient Information

  MAUDE report 50128713 ↗
• InjuryMay 11, 2026Fracture

  AS REPORTED: "DRILL BIT WAS FOUND BROKEN DURING SURGERY. DRILL BIT LEFT INSIDE PATIENT'S BODY AND SURGEONS AGREED NOT TO TAKE OUT THE LEFTOVER PART AND THE SURGERY WAS SUCCESSFULLY DONE."

  Patient problems: Foreign Body In Patient

  MAUDE report 25136680 ↗
• MalfunctionDec 16, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "DURING THE INSERTION OF SCREWS INTO THE TIBIO-PERONEAL BREAKAGE OF THE DRILL TIP OCCURRED WITHOUT THE POSSIBILITY OF REMOVING IT. PRESENCE OF METAL TIP INSIDE BONE."

  Patient problems: Foreign Body In Patient

  MAUDE report 20943749 ↗
• InjuryDec 16, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "DURING TIBIAL FRACTURE REDUCTION AND SYNTHESIS SURGERY A POINT-FORMED BREAKAGE OF THE DRILL OCCURRED. PRESENCE OF METAL TIP INSIDE THE BONE."

  Patient problems: Foreign Body In Patient

  MAUDE report 20943745 ↗
• MalfunctionDec 10, 2024Break; Fracture; Break; Fracture

  AS REPORTED: THE CS HAS REPORTED BROKEN DRILL.

  Patient problems: Insufficient Information

  MAUDE report 20888965 ↗
• InjuryJul 25, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "A DRILL BIT, REFERENCE 705025, FROM THE AXSOS ANCILLARY WE HAVE ON DEPOSIT, HAS JUST BROKEN DURING A TIBIA OSTEOSYNTHESIS. WHEN REMOVING THE WICK, THE OPERATOR NOTICED THAT THE END OF THE WICK WAS MISSING, CONFIRMED BY A SCAN. THE INCIDENT OCCURRED DURING THE OPERATION, WITH THE BROKEN PART REMAINING IN THE PATIENT'S TIBIA. THE OPERATION THEN CONTINUED."

  Patient problems: Foreign Body In Patient

  MAUDE report 19830910 ↗
• InjuryMar 12, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "ONE OF OUR AXSOS DRILLS HAS SNAPPED DURING A CASE. DRILL TIP IS INSITU IN TIBIAL PLATEAU AND PATIENT HAS BEEN INFORMED. "

  Patient problems: Foreign Body In Patient

  MAUDE report 18884453 ↗
• MalfunctionJan 8, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE DRILL BIT BROKE INSIDE THE PATIENT WHILE DRILLING. THIS WAS NOTICED AS THE DRILL BIT CAME OUT SHORTER.

  Patient problems: Foreign Body In Patient

  MAUDE report 18463252 ↗
• MalfunctionJan 8, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "IT WAS REPORTED THAT THE DRILL BIT BROKE INSIDE OF THE PATIENT AND COULD NOT BE RECOVERED."

  Patient problems: Foreign Body In Patient

  MAUDE report 18463179 ↗
• MalfunctionAug 4, 2023Break; Fracture; Break; Fracture

  AS REPORTED BY CUSTOMER: "DURING THE INSTALLATION OF MY PLATE AND FIXATION BY SCREWS OF AN OSTEOSYNTHESIS AT THE LEVEL OF A TIBIAL PLATEAU, THE DRILL BIT BROKE. PART OF THE DRILL BIT WAS STUCK IN THE BONE AND COULD NOT BE REMOVED. CLINICAL CONSEQUENCES: SERIOUS CLINICAL CONSEQUENCE: PART OF THE DRILL BIT BECAME STUCK IN THE BONE."

  Patient problems: Foreign Body In Patient

  MAUDE report 17462527 ↗
• MalfunctionApr 29, 2021Break; Break

  IT WAS REPORTED: THE TIP OF THE 2.5 DRILL BIT BROKE OFF AS IT ENCOUNTERED ANOTHER SCREW. THE 2.5 PERC DRILL BIT (703586) BROKE IN TIBIA WHILE DRILLING. SEVERAL HOLES WERE DRILLED SUCCESSFULLY IN THE TIBIA PRIOR THE EVENT. PATIENT HAD DECENTLY HARD BONE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH REPLACEMENT. TIPS OF DRILL BITS WERE LEFT IN PLACE AS RETRIEVAL WOULD HAVE POTENTIALLY CAUSED DAMAGE TO THE BONE.

  Patient problems: Foreign Body In Patient

  MAUDE report 11750919 ↗
• MalfunctionMar 16, 2021Break; Break

  IT WAS REPORTED: "THAT THE TIP OF 2.5 DRILL BIT BROKE OFF WHILE DRILLING FOR A 3.5 SCREW.THE SURGEON DID NOT ATTEMPT TO REMOVE AS THE TIP WAS EMBEDDED IN THE BONE. NO PATIENT IMPACT TO MY KNOWLEDGE".

  Patient problems: Foreign Body In Patient

  MAUDE report 11499243 ↗
• MalfunctionDec 7, 2020Fracture; Fracture

  AS REPORTED: "I WAS NOTIFIED BY A PHYSICIAN THAT A DRILL BIT BROKE INSIDE THE PATIENT'S BONE DURING AN ORIF TIBIA PLATEAU AT MEMORIAL HERMANN THE WOODLANDS ON MONDAY (B)(6) 2020. SURGEON WAS DRILLING THE MOST DISTAL HOLE OF THE PLATE AT AN ANGLE, AND THE DRILL BIT BROKE OFF IN THE FAR CORTEX. A SCREW WAS THEN INSERTED JUST PROXIMAL TO WHERE THE TIP OF THE DRILL WAS LEFT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10962728 ↗
• MalfunctionSep 2, 2020Fracture; Fracture

  IT WAS REPORTED: "DOCTOR PERFORMED A TIBIO-TALAR JOINT FUSION WITH USE OF AN ANTEROLATERAL STANDARD PLATE AND AN INDEPENDENT 6.5 CANNULATED SCREW. HER FEEDBACK IS MAINLY POSITIVE; HOWEVER, A DRILL BIT (705025) AND AN OLIVE WIRE BROKE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10482085 ↗
• MalfunctionMar 4, 2020Fracture; Fracture

  AS REPORTED: "DURING AN INTERVENTION FOR A COMPLEX FRACTURE OF PROXIMAL HUMERUS: TWO DRILL BITS D.2.5 BROKEN DURING THE PERFORATION OF THE HUMERAL SHAFT, THROUGH A HOLE IN THE PLATE. BROKEN DISTAL PART RECOVERED. A DRILL BIT D.3,1, BROKEN DURING THE PERFORATION OF THE HUMERAL HEAD, THROUGH A HOLE IN THE PLATE. BROKEN DISTAL PART RECOVERED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9788688 ↗
• MalfunctionMar 4, 2020Fracture; Fracture

  AS REPORTED: "DURING AN INTERVENTION FOR A COMPLEX FRACTURE OF PROXIMAL HUMERUS: TWO DRILL BITS D.2.5 BROKEN DURING THE PERFORATION OF THE HUMERAL SHAFT, THROUGH A HOLE IN THE PLATE. BROKEN DISTAL PART RECOVERED. A DRILL BIT D.3,1, BROKEN DURING THE PERFORATION OF THE HUMERAL HEAD, THROUGH A HOLE IN THE PLATE. BROKEN DISTAL PART RECOVERED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9788152 ↗
• MalfunctionDec 11, 2019Fracture; Fracture

  CUSTOMER REPORTED THAT: "BREAK AXSOS STRANDS, 2 YESTERDAY ON THE SAME PATIENT. REF (B)(4). THIS IS THE FOURTH TIME IT'S HAPPENED TO ME. THE WICK THEN REMAINS IN THE PATIENT'S BONE."

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

  MAUDE report 9455327 ↗
• MalfunctionAug 13, 2019Break; Fracture; Fracture

  DRILLS BROKE OFF DURING MEDICAL PROCEDURE. BROKEN PARTS WERE REMOVED. NOTHING REMAINED IN THE PATIENT. REPLACEMENT WAS AVAILABLE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8890592 ↗
• MalfunctionAug 13, 2019Break; Fracture; Detachment of Device or Device Component; Fracture

  DRILLS BROKE OFF DURING MEDICAL PROCEDURE. BROKEN PARTS WERE REMOVED. NOTHING REMAINED IN THE PATIENT. REPLACEMENT WAS AVAILABLE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8889386 ↗
• MalfunctionJan 17, 2019Break

  IT WAS REPORTED THAT THE DRILL BIT BROKE IN DIAPHYSIS OF TIBIAL SHAFT WHILE THE SURGEON WAS DRILLING DISTAL HOLES OF PROX LATERAL PLATE. IT WAS REPORTED THAT THE DRILL BIT BROKE RIGHT WHERE THE GOLD FLUTES OF THE DRILL MEET THE SOLID SILVER PORTION OF THE DRILL. IT WAS REPORTED THAT THE DRILL BIT TIP WAS LEFT IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 8256966 ↗
• MalfunctionJan 17, 2019Break

  IT WAS REPORTED THAT WHILE THE SURGEON WAS DRILLING DISTAL HOLE IN DIAPHYSIS, THE DRILL BIT BROKE. IT WAS REPORTED THAT IT BROKE RIGHT WHERE THE GOLD FLUTES OF THE DRILL MEET THE SOLID SILVER PORTION OF THE DRILL. IT WAS REPORTED THAT THE DRILL BIT TIP WAS LEFT IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 8256965 ↗
• MalfunctionJan 17, 2019Fracture; Fracture

  IT WAS REPORTED THAT WHILE THE SURGEON WAS DRILLING DISTAL HOLE IN DIAPHYSIS, THE DRILL BIT BROKE. IT WAS REPORTED THAT IT BROKE RIGHT WHERE THE GOLD FLUTES OF THE DRILL MEET THE SOLID SILVER PORTION OF THE DRILL. IT WAS REPORTED THAT THE DRILL BIT TIP WAS LEFT IN PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8256890 ↗
• MalfunctionSep 13, 2018Break

  IT WAS REPORTED THROUGH MEDWATCH " DURING ORIF PROCEDURE OF COMMINUTED TIBIA FRACTURE, A SCREW BIT WAS DRILLED WITHIN THE PROXIMAL TIBIA AND BROKE WITHIN THE TIBIA. THE SURGEON KEPT THE DRILL BIT INTACT AS REMOVING IT WOULD CAUSE MORE HARM, AS HE WOULD HAVE HAD TO REMOVE THE PLATES AND SCREWS, CAUSING INSTABILITY WITHIN THE FRACTURE. INTENTIONALLY RETAINED FB DISCLOSED TO PATIENT BY SURGEON"

  Patient problems: Foreign Body In Patient

  MAUDE report 7875039 ↗
• MalfunctionApr 23, 2018Break

  DURING AXSOS SURGERY, THE DRILL BIT CONTACTED TO AN IMPLANT WHEN DRILLING AND WAS BROKEN. THE BROKEN PIECE OF THE DRILL BIT WAS COMPLETELY REMOVED FROM THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7452311 ↗