PINNACLE 2274-25-800Recalls & reported problems

Summary

The FDA's MAUDE database contains 151 adverse event reports that list this exact device (DI 10603295109136), received between Sep 14, 2017 and Sep 30, 2026 — classified as 151 malfunctions.

The most frequently reported specific device problem is “Break” (130 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 151 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Break

  It was reported that the drill bit broke while being used to drill holes for screws in the acetabulum during the surgery. The broken piece was retrieved easily. A new drill bit was opened to complete the procedure. There was no significant delay. There was no reported patient or user harm. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948224 ↗
• MalfunctionAug 6, 2026Break; Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50164335 ↗
• MalfunctionMay 21, 2026Mechanical Jam

  IT WAS REPORTED THAT PRIOR TO A TOTAL HIP REPLACEMENT SURGERY, THE RATCHET WAS NOT WORKING. IT WAS NOTICED BEFORE USE. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25241078 ↗
• MalfunctionMay 20, 2026Material Deformation

  WAS THE PRODUCT BEING USED IN A CLINICAL TRIAL? NO. DID THE EVENT HAPPEN DURING A PROCEDURE? YES. WERE YOU IN THE PROCEDURE AT THE TIME OF THE EVENT? NO. EVENT OUTCOME/HOW WAS IT MANAGED? A DIFFERENT DRILL ON THE SET WAS USED WAS THERE ANY CONSEQUENCE TO THE PATIENT DUE TO THE EVENT? NO. WAS THE SURGERY PROLONGED DUE TO THE EVENT? NO. HAS THE REPORTER FACILITY INDICATED THERE MAY BE LEGAL ACTION? NO. PLEASE GIVE A DETAILED DESCRIPTION OF THE EVENT: THE DRILL BENT DURING NORMAL USE SO A DIFFERENT LENGTH DRILL FROM THE SET WAS USED TO FINISH THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25234381 ↗
• MalfunctionApr 13, 2026Break

  HIP DRILL INSTRUMENTS TO BE DAMAGED AND REQUIRE REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24865489 ↗
• MalfunctionMar 12, 2026Break

  IT WAS REPORTED THAT THE DRILL BROKE WHILE IN USE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24584055 ↗
• MalfunctionFeb 12, 2026Break

  IT WAS REPORTED THAT THE DRILL BIT BROKE DURING USE - BOTH PIECES REMOVED WITH NO EFFECT ON PATIENT. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24322247 ↗
• MalfunctionJan 9, 2026Break

  IT WAS REPORTED THAT PINNACLE REVISION DOME DRILL BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24024442 ↗
• MalfunctionDec 22, 2025Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE BURIC BROKE INTO TWO PIECES. IT WAS REPORTED THAT THE SURGERY TIME WAS NOT EXTENDED AS A DIRECT RESULT OF INCIDENT. THE PROCEDURE WAS COMPLETED WITH SAME LIKE PRODUCT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23865066 ↗
• MalfunctionDec 18, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE PIN REV DOME DRILL BROKE IN HALF. THERE WERE NO PATIENT CONSEQUENCES AND NO SURGICAL DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23840978 ↗
• MalfunctionNov 13, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE DRILL BIT BROKE INTO TWO PIECES. IT WAS REPORTED THAT ALL BROKEN PIECES WERE RECOVERED. THERE WAS NO REPORT OF PATIENT HARM OR DELAY IN SURGERY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23542386 ↗
• MalfunctionNov 4, 2025Break; Break

  IT WAS REPORTED THAT THE DRILL BROKE AND SNAPPED IN HALF WHILE BEING USED. IT WAS REPORTED THAT THE FRAGMENTS WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. IT WAS REPORTED THAT THERE WAS NO DELAY IN THE SURGERY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: Insufficient Information

  MAUDE report 23466718 ↗
• MalfunctionOct 27, 2025Break; Break

  IT WAS REPORTED THAT THE DRILLS FROM THE PINNACLE SET SNAPPED, AND THE T HANDLE CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23392436 ↗
• MalfunctionSep 17, 2025Break; Break

  IT WAS REPORTED THAT HOSPITAL WAS MISSING TWO 25MM DRILL PIECES FROM THE PINNACLE SCREW TRAY AND FLAGGED WITH THEIR SCRUB TEAM AND THEN THE INSTRUMENT COORDINATOR. THE TEAM NOTED THAT THESE HAVE BEEN MISSING FOR SOME TIME. THE SURGEON HAD BEEN USING MODULAR DRILL PIECES OR 25MM DRILL PIECES IN SURGERY IN PLACE OF THE 35MM WITH NO ISSUES. STAFF THOUGHT THESE HAD BEEN BROKEN FOR APPROXIMATELY SIX MONTHS. BOTH ITEMS ARE CONSIGNMENT SCREW PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23075498 ↗
• MalfunctionSep 17, 2025Break; Break

  IT WAS REPORTED THAT HOSPITAL WAS MISSING TWO 25 MM DRILL PIECES FROM THE PINNACLE SCREW TRAY AND FLAGGED WITH THEIR SCRUB TEAM AND THEN THE INSTRUMENT COORDINATOR. THE TEAM NOTED THAT THESE HAVE BEEN MISSING FOR SOME TIME. THE SURGEON HAD BEEN USING MODULAR DRILL PIECES OR 25 MM DRILL PIECES IN SURGERY IN PLACE OF THE 35 MM WITH NO ISSUES. STAFF THOUGHT THESE HAD BEEN BROKEN FOR APPROXIMATELY SIX MONTHS. BOTH ITEMS ARE CONSIGNMENT SCREW PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23075496 ↗
• MalfunctionJul 17, 2025Break; Break

  IT WAS REPORTED THAT THERE WAS BREAKAGE AND REPAIR OF CONSIGNED ITEMS IN THE ACCOUNT FROM GENERAL USAGE. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22532131 ↗
• MalfunctionJul 17, 2025Break; Break

  IT WAS REPORTED THE DEVICES WERE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22532097 ↗
• MalfunctionJul 17, 2025Break; Break

  IT WAS REPORTED THE DEVICES WERE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22531978 ↗
• MalfunctionJul 17, 2025Break; Break

  IT WAS REPORTED THE DEVICES WERE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22531880 ↗
• MalfunctionJul 17, 2025Break; Break

  IT WAS REPORTED THE DEVICES WERE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22531847 ↗
• MalfunctionJul 11, 2025Break; Break

  IT WAS REPORTED THAT THE DRILL BIT BROKE IN HALF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22482034 ↗
• MalfunctionJul 10, 2025Break; Break

  IT WAS REPORTED THAT THE DRILL BROKE INTO TWO PIECES, ALL WAS REMOVED FROM PATIENT. NO PATIENT HARM AND NO SURGICAL DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22467797 ↗
• MalfunctionMay 14, 2025Break; Break

  IT WAS REPORTED THAT THE DRILL BIT BROKE IN HALF INTO ONE PIECE DURING NORMAL USE. THERE WAS NO ADVERSE EVENTS TO THE PATIENT, NO DELAYS IN THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22021299 ↗
• MalfunctionMar 28, 2025Break; Break

  IT WAS REPORTED THAT THE TWO 25MM DRILL BITS BROKE AS THE SURGEON WAS DRILLING HOLES FOR THE CUP. ALL BROKEN PIECES WERE RETRIEVED BUT WERE LOST DURING DECONTAMINATION BY SPD. NO DELAY IN CASE.

  Patient problems: Insufficient Information

  MAUDE report 21724058 ↗
• MalfunctionMar 18, 2025Break; Break

  IT WAS REPORTED A 25 MM PINN REVISION BROKE DURING USE INTRAOPERATIVELY. NO PATIENT IMPACT. NO SURGICAL DELAY. NO FRAGMENTS. AS PER HOSPITAL POLICY THE DRILL BIT WAS DISCARDED .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21634886 ↗