PINNACLE 2274-30-800Recalls & reported problems

Summary

The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 10603295109150), received between Aug 16, 2017 and Feb 26, 2026 — classified as 79 malfunctions.

The most frequently reported specific device problem is “Break” (54 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 79 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2026Material Deformation

  IT WAS REPORTED THAT THE DRILL BIT BENT WHILE DRILLING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24455481 ↗
• MalfunctionFeb 11, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT PINNACLE REVISION DOME DRILL BROKE. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE PIN REV DOME DRILL 30MM IT WAS IDENTIFIED THAT THE COIL SHAFT BENT AND BROKEN NEAR TO THE FLUTED TIP, AND THE FRAGMENTS REMAINED ATTACHED TO THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24316190 ↗
• MalfunctionJan 9, 2026Break

  IT WAS REPORTED THAT DRILL BIT WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24026428 ↗
• MalfunctionJan 8, 2026Break

  IT WAS REPORTED THAT A DRILL BIT SNAPPED WHILE DRILLING DURING SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24011897 ↗
• MalfunctionNov 10, 2025Break; Break

  IT WAS REPORTED THAT DRILL BIT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23517019 ↗
• MalfunctionOct 21, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DRILL BITS WERE DULL. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23347397 ↗
• MalfunctionJul 28, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A TOTAL HIP ARTHROPLASTY SURGERY WAS PERFORMED. THE SURGERY WAS CARRIED OUT USING CORAIL & PINNACLE INSTRUMENTS AND MATERIALS. FOLLOWING THE IMPLANTATION OF THE ACETABULAR SHELL WITH ¿ PINNACLE ACETABULAR SHELL SECTOR II WITH POROCOAT 50MM OD, THE SURGEON PROCEEDED, IN ACCORDANCE WITH THE STANDARD PROCEDURE, TO DRILL THROUGH THE BONE VIA THE HOLES IN THE ACETABULAR SHELL USING THE DRILL BIT PIN REV DOME DRILL 30MM. DURING THE DRILLING PROCESS, IT WAS FOUND THAT THE AFOREMENTIONED DRILL BIT FRACTURED, AND THE LARGER PART REMAINED INSIDE THE PATIENT'S BONE. THE OPERATION WAS COMPLETED WITH A SIGNIFICANT DELAY, WITH THE BROKEN PIECE OF THE DRILL BIT REMAINING INSIDE THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22631633 ↗
• MalfunctionFeb 6, 2025Break; Break

  IT WAS REPORTED THE DEVICE WAS BROKEN ON AN UNKNOWN DATE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21326464 ↗
• MalfunctionJan 6, 2025Break; Break

  IT WAS REPORTED THAT THE DRILL BIT BROKE DURING PROCEDURE. THERE WAS NO SURGICAL DELAY. THE FRAGMENTS WERE EASILY REMOVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21077987 ↗
• MalfunctionAug 26, 2024Break; Break

  IT WAS REPORTED THAT THE DRILL BITS BROKE DURING SURGERY, HOWEVER NO HARM TO PATIENT OCCURRED AS A RESULT OF THIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20065659 ↗
• MalfunctionJun 6, 2024Break; Break

  IT WAS REPORTED THAT DURING DRILLING FOR A SCREW THE DRILL BIT TIP BROKE OFF THE REVISION 30MM DONE DRILL SHAFT. TIP WAS LOCATED AND REMOVED. USED ANOTHER DRILL SHAFT TO COMPLETE CASE. SURGEON HAPPY NO PARTICLES LEFT IN PATIENT. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19475747 ↗
• MalfunctionMay 22, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT THE BITS ARE BENT OR SNAPPED OFF. NO LONGER FUNCTIONAL.

  Patient problems: Insufficient Information

  MAUDE report 19370257 ↗
• MalfunctionDec 4, 2023Break; Break

  IT WAS REPORTED THAT THE BOTH 25 AND 30MM DRILL BITS SNAP DURING USE. ALL PARTS WERE RETRIEVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18263816 ↗
• MalfunctionNov 15, 2023Break; Break

  IT WAS REPORTED THAT DOME DRILLS TIP WAS BROKEN. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? --> UNKNOWN, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? --> UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18145561 ↗
• MalfunctionNov 13, 2023Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED: A. DID IT BROKE INTO TWO OR MORE PIECES? 2 PIECES B. WERE THERE ANY FRAGMENTS GENERATED? IF YES, WERE ALL THE PIECES RETRIEVED? NO FRAGMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18124657 ↗
• MalfunctionNov 9, 2023Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT THE DOME DRILL BROKE INTRA-OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18104903 ↗
• MalfunctionAug 15, 2023Break; Break

  IT WAS REPORTED THAT DEVICE WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17549821 ↗
• MalfunctionApr 24, 2023Break; Break

  IT WAS REPORTED DEVICE IS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16796476 ↗
• MalfunctionApr 24, 2023Break; Break

  IT WAS REPORTED THAT THE TIP OF A 30MM DRILL BIT BROKE OFF WHILE DRILLING FOR A SCREW. ALL PIECES WERE RETRIEVED. THERE WAS NO HARM TO THE PATIENT AND THE SURGERY WAS NOT DELAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16796176 ↗
• MalfunctionDec 16, 2022Break; Break

  IT WAS REPORTED THAT 30MM DRILL TIP BROKE INTO TWO PIECES. TIP WAS REMOVED FROM PATIENT. DRILL HAS BEEN REPROCESSED AND USED MULTIPLE TIMES. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15995960 ↗
• MalfunctionOct 6, 2022Break; Break

  IT WAS REPORTED THAT THE DRILL BIT BROKE IN HALF WHEN DRILLING SCREWS FOR THE ACETABULUM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15550560 ↗
• MalfunctionMay 23, 2022Break; Break

  IT WAS REPORTED THAT 30 MM FLEXIBLE DRILL BIT BROKE WHILE DRILLING FOR SCREWS. THERE IS NO REPORTED SURGICAL DELAY. ALL PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14471452 ↗
• MalfunctionMay 7, 2022Break; Break

  IT WAS REPORTED THAT DRILL BIT BROKE INTO TWO PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14316440 ↗
• MalfunctionMar 9, 2022Break; Material Deformation; Break; Material Deformation

  INSTRUMENTS WERE FOUND BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13714019 ↗
• MalfunctionMar 3, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT 2 DRILL FLEX DRILL BIT TIPS BENT 90 DEGREES. NEED REPLACEMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13660365 ↗