NA 2274-02-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 303 adverse event reports that list this exact device (DI 10603295109020), received between Jun 28, 2017 and Sep 29, 2026 — classified as 1 injury, 302 malfunctions.

The most frequently reported specific device problem is “Break” (112 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 303 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Break; Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936313 ↗
• MalfunctionSep 14, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50764867 ↗
• MalfunctionSep 10, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722046 ↗
• MalfunctionSep 10, 2026Break

  It was reported that the grey Screw driver handle lock mechanism broke.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50714063 ↗
• MalfunctionSep 2, 2026Mechanical Jam

  It was reported that the screwdriver handle no longer ratchets. It was reported that there was no delay in the procedure due to the event. There were no adverse consequences to the patient. No additional information could be provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50572008 ↗
• MalfunctionMay 29, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE PINNACLE 25MM DRILL BIT WAS BLUNT, AND THE METAL RING FROM PINNACLE SCREWDRIVER HANDLE FROM PINNACLE SCREW TRAY WAS LOOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25337081 ↗
• MalfunctionMay 26, 2026Material Integrity Problem

  IT WAS REPORTED THAT THE T HANDLE HAS A CRACK IN IT AND THE SCREW DRIVER HANDLES COLLAR WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25277084 ↗
• MalfunctionApr 10, 2026Break

  IT WAS REPORTED THAT THE SCREWDRIVER HANDLE WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24845160 ↗
• MalfunctionApr 7, 2026Break

  IT WAS REPORTED THAT DURING CUP IMPLANTATION TWO DRILL BITS, SCREWDRIVER AND A SCREWDRIVER HANDLE WERE BROKEN. NO PIECES WERE LOST. RATCHET HANDLE WORKED POORLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24808906 ↗
• MalfunctionMar 4, 2026Break

  IT WAS REPORTED THAT RUBBER ON SCREWDRIVER IS TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24514232 ↗
• MalfunctionMar 3, 2026Break; Device-Device Incompatibility; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED PROVIDING ANSWERS FROM THE FOLLOWING QUESTIONS: 1. DID IT BREAK INTO TWO OR MORE PIECES? IF YES, WERE ALL THE FRAGMENTS RETRIEVED FROM THE PATIENT? IF NO, PLEASE SPECIFY WHAT IS THE ALLEGED DEFICIENCY, IS IT BENT, CRACKED, STRIPPED, SCRATCHED, WORN OR CROSS THREADED? - THE DRIVER DID NOT BREAK, IT IS STILL COMPLETE IN ONE PIECE. IT IS NOT BENT BUT POSSIBLE STRIPPED OR CROSS THREADED. IT IS THE TORQUE LOCKING MECHANISM THAT IS MALFUNCTIONING, WHILE ATTEMPTING TO TIGHTEN/LOOSEN A SCREW. ALL OF THE OTHER INFORMATION WAS ALREADY GIVEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24499784 ↗
• MalfunctionFeb 20, 2026Break

  IT WAS REPORTED THAT THE SPRING BROKE OFF FROM THE SCREWDRIVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24402783 ↗
• MalfunctionJan 24, 2026Mechanical Jam

  IT WAS REPORTED THAT THE RATCHET FUNCTION OF THE SCREWDRIVER HANDLE WAS NO LONGER WORKING WHILE IMPLANTING A CANCELLOUS BONE SCREW. IT WAS REPORTED THAT SURGICAL TIME WAS NOT EXTENDED AND NO ADVERSE CONSEQUENCES FOR THE PATIENT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24173644 ↗
• MalfunctionJan 9, 2026Mechanical Jam

  IT WAS REPORTED THAT THE RATCHET HANDLE WOULD NOT RATCHET FORWARD AND ONLY MOVED BACKWARD, REVERSING THE SCREW. A BACKUP SET WAS OPENED AND THERE WAS NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24024432 ↗
• MalfunctionDec 23, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT DURING STERILE PROCESSING IT WAS OBSERVED THAT THE SCREWDRIVER HANDLE HAD SOMETHING STUCK IN THE CANNULATED HOLE AND RP PS ARTIC SURFACE HAD A BROKEN PEG. NOTHING FURTHER TO REPORT. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23882292 ↗
• MalfunctionDec 3, 2025Break; Break

  IT WAS REPORTED THAT ONE RATCHET HANDLE FROM THE PINNACLE CORE SET WAS DAMAGED AND WAS BROKEN. THE FAILURE WAS NOT ATTRIBUTABLE TO WEAR AND TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23708730 ↗
• MalfunctionDec 2, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  PINNACLE RATCHET HANDLE WAS NOT WORKING AS IT SHOULD DURING THE CASE. UNABLE TO WIND FROM 'REVERSE' TO 'FORWARD' TO PLACE ACETABULAR SCREW AND RATCHET WAS NOT WORKING. ENDED UP HAVING TO PLACE SCREW MANUALLY WITH THE SCREWDRIVER. I TESTED THIS ONCE CASE WAS FINISHED, AND THE RATCHET HANDLE DOES NOT FUNCTION AS IT SHOULD. SURGEON HAS REQUESTED TO HAVE THIS REPLACED OUT WITH A NEW ONE IN THE SET (LIR TO BE COMPLETED BY MYSELF ONCE PC LODGED). CUSTOMER HAS REQUESTED TO HOLD THIS ITEM IN THE TRAY UNTIL A REPLACEMENT CAN BE SOURCED. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, ACTION TAKEN WHEN EVENT OCCURRED? SURGEON MENTIONED TO ME THAT RATCHET HANDLE WAS NOT WORKING AS IT SHOULD AND REQUESTED THAT I SORT A REPLACEMENT., WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? NO, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: NO, IS THE PATIENT PART OF A CLINICAL STUDY NO, DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23691623 ↗
• MalfunctionNov 18, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TORQUE LIMITING FUNCTION ON A SCREWDRIVER WAS NOT WORKING DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23583160 ↗
• MalfunctionNov 10, 2025Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT SCREWDRIVER HANDLE WAS NOT RATCHET, SOMETHING IN THE INNER DRIVER WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23513932 ↗
• MalfunctionNov 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DIRECTION KNOB CAME APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23487569 ↗
• MalfunctionOct 27, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE SCREWDRIVER WILL NOT RATCHET ANYMORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23393464 ↗
• MalfunctionOct 21, 2025Break; Break

  IT WAS REPORTED THAT THERE WAS A BROKEN LOCKING GUARD AT BASE OF SCREW HANDLE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23349158 ↗
• MalfunctionOct 16, 2025Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP REPLACEMENT SURGERY. THE SURGEON HIT THE RATCHETING COLLAR ON THE SCREWDRIVER TO GET THE HANDLE OF THE SCREW AND BROKE THE COLLAR. THERE WAS NO DELAY IN CASE OR CONSEQUENCE TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23309904 ↗
• MalfunctionSep 12, 2025Break; Break

  IT WAS REPORTED THE HUDSON/CHUCK IS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23042521 ↗
• MalfunctionSep 4, 2025Break; Break

  IT WAS REPORTED THAT DURING SURGERY THAT THE SCREWDRIVER HANDLE WITH RATCHET WAS DAMAGED, BUT STILL IT WAS POSSIBLE TO SOLVE THE ISSUE BY SCREWING DIRECTLY WITH THE PIECE IN THE HAND AND USING A LARGE HANDLE THAT WAS INSIDE ANOTHER INSTRUMENT, THUS ACHIEVING TO FINISH THE SURGERY SUCCESSFULLY, WITHOUT AFFECTING THE PATIENT AND WITHOUT ALTERATIONS IN THE SURGICAL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22963761 ↗