PRO 703966Recalls & reported problems
Stryker GmbH · Scaled Drill , Ao Fitting · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Stryker scaled drill bit used for orthopedic surgery. Most of the 48 reports describe the bit tip snapping off during drilling, sometimes leaving the broken piece inside the patient or lodged in bone. Eleven reports involved injuries, and there were no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 49
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 07613252719861), received between Jan 8, 2019 and Aug 13, 2026 — classified as 12 injuries, 37 malfunctions.
The most frequently reported specific device problem is “Fracture” (40 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.
Reports received per month
Most reported problems
Device problems
- Fracture40
- Break34
- Detachment of Device or Device Component2
- Improper or Incorrect Procedure or Method1
Patient problems
- Foreign Body In Patient28
- No Clinical Signs, Symptoms or Conditions14
- Device Embedded In Tissue or Plaque4
- No Known Impact Or Consequence To Patient4
- Insufficient Information1
- Internal Organ Perforation1
Recent adverse event reports
The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.
InjuryAug 13, 2026Fracture
It was reported that, during the procedure the tip of the Stryker drill bit broke off and was retained in the patient's pelvic bone. Patient had a fractured acetabulum following a dirt bike accident and was taken to the operating room for an ORIF (open reduction and internal fixation).
Patient problems: Foreign Body In Patient
MAUDE report 50245093 ↗InjuryJun 8, 2026Fracture
AS REPORTED: "DURING THE PELVIC OPEN REDUCTION AND INTERNAL FIXATION (ORIF) PROCEDURE, IT WAS NOTED THAT WHILE DRILLING THROUGH DENSE BONE, THE TIP OF A DRILL BIT BROKE OFF AND REMAINED INSIDE THE PATIENT."
Patient problems: Foreign Body In Patient
MAUDE report 25429685 ↗InjuryMay 28, 2026Fracture
IT WAS REPORTED THAT, THE BROKEN TIP OF THE DRILL WAS REMAINED TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 25325413 ↗MalfunctionApr 27, 2026Fracture
IT WAS REPORTED THAT, THE DRILL WAS BROKEN. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 25008521 ↗MalfunctionApr 2, 2026Fracture
AS REPORTED: "THE DRILL BIT TIP HAS BROKEN." THE HCP CONFIRMED THAT ALTHOUGH FRAGMENTS WERE PRESENT, THEY HAD ALL BEEN REMOVED AND NONE REMAINED INSIDE THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24769036 ↗InjuryFeb 25, 2026Fracture
AS REPORTED: "THE DRILL BIT FRACTURED DURING THE SURGERY. IT REMAINS WITHIN THE BONE."
Patient problems: Foreign Body In Patient
MAUDE report 24446633 ↗MalfunctionNov 5, 2025Fracture; Fracture
IT WAS REPORTED VIA MEDWATCH MW5175954: DRILL BIT X3 BROKE OFF IN BONE.
Patient problems: Foreign Body In Patient
MAUDE report 23478009 ↗MalfunctionNov 5, 2025Fracture; Fracture
IT WAS REPORTED VIA MEDWATCH MW5175953: DRILL BIT X3 BROKE OFF IN BONE.
Patient problems: Foreign Body In Patient
MAUDE report 23478004 ↗MalfunctionNov 5, 2025Fracture; Fracture
IT WAS REPORTED VIA MEDWATCH MW5175955: DRILL BIT X3 BROKE OFF IN BONE.
Patient problems: Foreign Body In Patient
MAUDE report 23478003 ↗MalfunctionOct 20, 2025Fracture; Fracture
AS REPORTED: "ORIF FOR PELVIC FRACTURE. DRILL FRACTURED DURING DRILLING."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23342579 ↗InjuryAug 28, 2025Break; Fracture; Break; Fracture
AS REPORTED: "DISTRIBUTOR INFORMED SALES REP THAT TWO DRILLS (703966) APPEAR TO HAVE BROKEN DURING SURGERY FOR A PELVIC FRACTURE. SALES REP IS CURRENTLY CONFIRMING THE HEALTH HAZARD TO THE PATIENT AND MEDICAL INTERVENTION, BUT NO FURTHER INFORMATION HAS BEEN PROVIDED BY HCP AT THIS TIME." ADDITIONAL INFORMATION RECEIVED AUGUST 4, 2025. THE DOCTOR REPORTED, ¿THE PATIENT'S BONES WERE VERY HARD, AND DRILLING WAS PERFORMED WITH THE SURROUNDING SOFT TISSUE PUTTING STRESS ON THE DRILL.¿ A BROKEN PIECE OF THE DRILL PENETRATED INTO THE BONE, BUT WAS DIFFICULT TO REMOVE, SO THE PROCEDURE WAS COMPLETED WITH THE BROKEN PIECE LEFT INSIDE THE BODY.
Patient problems: Foreign Body In Patient
MAUDE report 22912506 ↗InjuryMay 13, 2025Break; Fracture; Break; Fracture
AS REPORTED: THE DRILL WAS DAMAGED DURING DRILLING INTO THE BONE. THE BROKEN DRILL TIP REMAINED INSIDE THE PATIENT BONE.
Patient problems: Foreign Body In Patient
MAUDE report 22011339 ↗InjuryMay 7, 2025Break; Fracture; Break; Fracture
AS REPORTED; "DRILL TIP BROKE OFF DURING SURGERY. THE FRAGMENT OF THE DRILL WAS REMAINED TO THE PATIENT. AFTER THE EVENT, THE SURGERY WAS COMPLETED USING AN ALTERNATIVE DRILL".
Patient problems: Foreign Body In Patient
MAUDE report 21980899 ↗MalfunctionApr 16, 2025Break; Fracture; Break; Fracture
AS REPORTED: "DRILL TIP BROKEN DURING PROCEDURE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21848020 ↗MalfunctionMay 7, 2024Break; Fracture; Break; Fracture
AS REPORTED: "DRILLING WAS PERFORMED USING THE USUAL TECHNIQUE. IMAGE CHECK BEFORE SCREW INSERTION REVEALED THAT THE DRILL TIP REMAINED IN THE BODY. THE BROKEN DRILL TIP WAS SAFELY REMOVED AND THE SURGERY WAS COMPLETED SUCCESSFULLY.".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19264351 ↗InjuryFeb 6, 2024Break; Fracture; Break; Fracture
AS REPORTED: "PATIENT WAS IN OPERATIVE ROOM UNDERGOING OPEN REDUCTION WITH INTERNAL FIXATION (ORIF) LEFT ACETABULUM. IN ORDER TO PLACE PELVIC SCREWS, A LONG STRYKER 2.5MM DRILL BIT WAS BEING USED. DURING DRILL USE, THE TIP OF THE DRILL BIT BROKE OFF AND THIS WAS IMMEDIATELY NOTICEABLE AS FLUOROSCOPY WAS USED THROUGHOUT THE PROCEDURE AS NEEDED. DOCTOR ATTEMPTED TO REMOVE THE THREADS, BUT BECAUSE THEY WERE UNABLE TO BE REMOVED EASILY, THE DRILL TIP WAS LEFT IN THE BONE IN ORDER TO PREVENT FURTHER TRAUMA TO THE BONE."
Patient problems: Foreign Body In Patient
MAUDE report 18652331 ↗InjuryJan 3, 2024Break; Fracture; Break; Fracture
AS REPORTED: "THE TIP OF A DRILL BIT WITH A DIAMETER OF 2.5 MM AND A TOTAL LENGTH OF 450 MM WAS BROKEN AND REMAINED INSIDE THE PATIENT'S BODY."
Patient problems: Foreign Body In Patient
MAUDE report 18435716 ↗MalfunctionNov 15, 2023Break; Fracture; Break; Fracture
AS REPORTED: "DURING PLACEMENT OF A PLATE ON A PELVIC FRACTURE, THE TWO DRILL BITS OF THE ANCILLARY BROKE OFF ONE AFTER THE OTHER AND BECAME STUCK IN THE PATIENT'S BONE. THERE WAS NO POSSIBILITY OF REMOVING THEM. PATIENT'S CURRENT CONDITION: THE DISTAL PART OF THE DRILL BITS REMAINED IN PLACE IN THE PELVIS. NO CLINICAL CONSEQUENCES OBSERVED."
Patient problems: Foreign Body In Patient
MAUDE report 18140167 ↗MalfunctionNov 15, 2023Break; Fracture; Break; Fracture
AS REPORTED: "DURING PLACEMENT OF A PLATE ON A PELVIC FRACTURE, THE TWO DRILL BITS OF THE ANCILLARY BROKE OFF ONE AFTER THE OTHER AND BECAME STUCK IN THE PATIENT'S BONE. THERE WAS NO POSSIBILITY OF REMOVING THEM. PATIENT'S CURRENT CONDITION: THE DISTAL PART OF THE DRILL BITS REMAINED IN PLACE IN THE PELVIS. NO CLINICAL CONSEQUENCES OBSERVED."
Patient problems: Foreign Body In Patient
MAUDE report 18140159 ↗MalfunctionNov 13, 2023Break; Fracture; Break; Fracture
THE CUSTOMER REPORTED THAT : "WE ARE CONTACTING YOU IN CONNECTION WITH AN INCIDENT THAT OCCURRED IN THE OR DURING THE PLACEMENT OF A PLATE ON A PELVIC FRACTURE. TWO DRILL BITS FROM THE 2.5MM 300MM ANCILLARY BROKE DURING THE PROCEDURE, REMAINING IN THE PATIENT'S BONE."
Patient problems: Foreign Body In Patient
MAUDE report 18119138 ↗MalfunctionNov 13, 2023Break; Fracture; Break; Fracture
THE CUSTOMER REPORTED THAT : "WE ARE CONTACTING YOU IN CONNECTION WITH AN INCIDENT THAT OCCURRED IN THE OR DURING THE PLACEMENT OF A PLATE ON A PELVIC FRACTURE. TWO DRILL BITS FROM THE 2.5MM 300MM ANCILLARY BROKE DURING THE PROCEDURE, REMAINING IN THE PATIENT'S BONE."
Patient problems: Foreign Body In Patient
MAUDE report 18119107 ↗MalfunctionOct 10, 2023Break; Fracture; Break; Fracture
IT WAS REPORTED THAT A 2.5 LONG DRILL BIT BROKE AND A 2.3CM TIP RETAINED INSIDE A PATIENT'S RIGHT SIDE ILIUM BONE. IT WAS DECIDED TO NOT BE REMOVED.
Patient problems: Foreign Body In Patient
MAUDE report 17907122 ↗MalfunctionOct 2, 2023Break; Fracture; Break; Fracture
AS REPORTED: "DRILL BIT BROKEN OFF DURING SURGERY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17850599 ↗MalfunctionSep 14, 2023Break; Fracture; Break; Fracture
IT WAS REPORTED THAT A DRILL TIP BROKE INSIDE A PATIENT. THE PROCEDURE WAS COMPLETED BY USING A SECOND DRILL BIT AND IMAGING CONFIRMED THAT THE DRILL BIT REMAINED IN THE PATIENTS BONE.
Patient problems: Foreign Body In Patient
MAUDE report 17744761 ↗MalfunctionAug 14, 2023Break; Fracture; Break; Fracture
AS REPORTED: "BREAKAGE OF DRILL TIP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17546748 ↗
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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