PINNACLE 2274-35-800Recalls & reported problems

Summary

The FDA's MAUDE database contains 105 adverse event reports that list this exact device (DI 10603295109181), received between Aug 25, 2017 and Sep 30, 2026 — classified as 1 injury, 104 malfunctions.

The most frequently reported specific device problem is “Break” (66 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 105 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947868 ↗
• MalfunctionJun 9, 2026Break

  IT WAS REPORTED THAT 35MM FLEXIBLE DRILL BIT BROKE IN THE MIDDLE OF THE FLUTES WHILE DRILLING FOR A CANCELLOUS BONE SCREW. BOTH PIECES WERE RETRIEVED. SURGICAL TIME WAS NOT EXTENDED AND NO ADVERSE CONSEQUENCES FOR THE PATIENT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25443522 ↗
• MalfunctionApr 20, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE DRILL BIT BROKE/SNAPPED INTO 2 PIECES DURING NORMAL USE. IT WAS REPORTED THAT THERE WAS NO SURGICAL DELAY, AND NO ADVERSE PATIENT CONSEQUENCES. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24925151 ↗
• MalfunctionApr 6, 2026Break

  WHILE PERFORMING A HIP REPLACEMENT, TWO DRILL BITS WERE SNAPPED INTO TWO PIECES. ALL THE FRAGMENTS WERE RETRIEVED; HOWEVER, BOTH DRILL BITS WERE DISPOSED OF. NO PATIENT HARM, NO X-RAYS, NO DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24793396 ↗
• MalfunctionApr 6, 2026Break

  WHILE PERFORMING A HIP REPLACEMENT, TWO DRILL BITS WERE SNAPPED INTO TWO PIECES. ALL THE FRAGMENTS WERE RETRIEVED; HOWEVER, BOTH DRILL BITS WERE DISPOSED OF. NO PATIENT HARM. NO X-RAYS . NO DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24793392 ↗
• MalfunctionMar 20, 2026Break

  IT WAS REPORTED THAT THE INSTRUMENT SNAPPED IN HALF. THERE WERE NO FRAGMENTS LEFT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24647669 ↗
• MalfunctionJan 20, 2026Break

  IT WAS REPORTED THAT THE DRILL END HAS BROKEN IN TWO. BOTH BITS WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24117186 ↗
• MalfunctionJan 16, 2026Break

  IT WAS REPORTED THAT THE DRILL BROKE DURING A PROCEDURE. THE BROKEN PIECE WAS RETRIEVED WITH NO ISSUE AND A DIFFERENT DRILL FROM THE SET WAS USED TO COMPLETE THE SURGERY. THERE WAS NO SURGICAL DELAY AND THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24103333 ↗
• MalfunctionJan 16, 2026Break

  DURING A PROCEDURE, THE DRILL BROKE DURING USE. THE BROKEN PIECE WAS RETRIEVED ON BOTH OCCASIONS WITH NO ISSUE AND A DIFFERENT DRILL FROM THE SET WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24094586 ↗
• MalfunctionDec 8, 2025Break; Break

  IT WAS REPORTED THAT DRILL BIT BROKE DURING THE CASE AND WAS THROWN OUT BY SCRUB TECH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23749265 ↗
• MalfunctionAug 19, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DRILL BROKE INTO TWO PIECES. PROCEDURE WAS COMPLETED WITH SAME LIKE PRODUCT. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22842346 ↗
• MalfunctionJul 31, 2025Break; Break

  IT WAS REPORTED THAT THE ITEM SNAPPED INTO TWO PIECES WHILE IT WAS IN USE. BOTH PIECES WERE RETRIEVED. THERE WAS NO PATIENT HARM, AND NO DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22675220 ↗
• MalfunctionJul 7, 2025Break; Break

  IT WAS REPORTED THAT MULTIPLE DRILL BITS WERE BROKEN DURING SURGERY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22410795 ↗
• MalfunctionJun 26, 2025Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE SURGEON WAS DRILLING A SCREW HOLE IN A PINNACLE CUP AND THE DRILL BROKE. THE BROKEN PIECE WAS RETRIEVED AND A DIFFERENT DRILL WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT CONSEQUENCE, AND THE SURGERY WAS NOT PROLONGED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22335633 ↗
• MalfunctionJun 19, 2025Break; Break

  IT WAS REPORTED THAT A 35MM DRILL BIT BROKE WHILE ATTEMPTING TO DRILL ACETABULUM. NOTHING WAS LEFT IN PATIENT. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22293753 ↗
• MalfunctionJun 5, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP REPLACEMENT ON (B)(6) 2025. THE DRILL BIT BROKE OFF IN THE PATIENT WHILE DRILLING A HOLE FOR SCREWS. A FRAGMENT WAS LEFT IN THE LEFT SIDE OF THE PELVIS, SUPERIOR TO THE CUP. SURGEON DEEMED IT UNRETRIEVABLE WITHOUT RISK FAR GREATER THAN LEAVING IT IN FOR NOW. PROCEDURE WAS COMPLETED WITH A THIRTY MINUTE DELAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 22149524 ↗
• MalfunctionApr 3, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, A DRILL PIECE SNAPPED IN TWO. BOTH PARTS WERE RETRIEVED. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21766781 ↗
• MalfunctionMar 31, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING PROCEDURE THE DRILL WAS FOUND TO BE BLUNT DURING USE SO A DIFFERENT DRILL FROM THE SAME SET WAS USED. THERE WAS NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS REVEALED THAT THE TIP BROKEN FROM PIN REV DOME DRILL 35MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21732999 ↗
• MalfunctionFeb 19, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRILL BIT BROKE WHEN DRILLING THE ACETABULUM. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21411944 ↗
• MalfunctionJan 15, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT SURGERY, THE DRILL BIT BROKE WHILE IN USE. UNABLE TO LOCATE BROKEN PIECE INSIDE THE PATIENT DESPITE ATTEMPT TO REMOVE CUP TO TRY AND LOCATE AND RETRIEVE BROKEN INSTRUMENT. SURGEON WAS UNABLE TO LOCATE AND SO DECIDED TO CONTINUE IMPLANTING CUP, LEAVING DRILL BIT FRAGMENT INSIDE THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21158956 ↗
• MalfunctionDec 13, 2024Break; Break

  IT WAS REPORTED THAT THE REVISION DOME DRILL BIT WAS BROKEN. THERE WERE NO PATIENT CONSEQUENCES. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20925868 ↗
• MalfunctionOct 2, 2024Break; Break

  IT WAS REPORTED THAT THE BORIC WAS BROKEN INTO TWO PIECES INTRAOPERATIVELY. SIMILAR PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20353084 ↗
• MalfunctionAug 26, 2024Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20065941 ↗
• MalfunctionJun 4, 2024Break; Break

  IT WAS REPORTED THAT THE DRILL BROKE OF INTO TWO PIECES. PATIENT WAS NOT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19457729 ↗
• MalfunctionJun 3, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  THE DRILL BIT BROKE OFF AND GOT STUCK IN THE FLEXI DRILL SHAFT MAKING IT UNUSABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19447573 ↗