ATTUNE 2545-00-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 153 adverse event reports that list this exact device (DI 10603295130574), received between Jun 22, 2017 and Sep 16, 2026 — classified as 153 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (90 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 153 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Device-Device Incompatibility

  It was reported that the pin puller is damaged from a loaner set. Surgeon needed to clench abnormally hard to use the pin puller.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50785783 ↗
• MalfunctionSep 10, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722902 ↗
• MalfunctionSep 10, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722900 ↗
• MalfunctionMay 8, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE ATTUNE PIN PULLER WAS DEFECTIVE DURING SURGERY INVOLVING A TOTAL KNEE PROSTHESIS. THE DEVICE DID NOT CLOSE PROPERLY, RESULTING IN ITS INABILITY TO PERFORM ITS INTENDED FUNCTION OF HOLDING ANOTHER DEVICE OR POSITION. THERE WERE NO CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25122123 ↗
• MalfunctionApr 23, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE SPRINGS WERE GONE ON THE ATTUNE SPACER BLOCK, AND THE ATTUNE PIN JACK WILL NOT JACK OFF THE PINS ANYMORE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24965800 ↗
• MalfunctionMar 11, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A TOTAL KNEE REPLACEMENT PROCEDURE, THE PIN PULLER WASN¿T WORKING AND COULDN¿T REMOVE THE PIN FROM THE BONE. SURGEON USED THE PIN DRIVER, WHICH IS ANOTHER OPTION. NO HARM TO THE PATIENT, NO DELAYS, NO X-RAYS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24571758 ↗
• MalfunctionFeb 6, 2026Break

  IT WAS REPORTED THAT THE ATTUNE PIN PULLER WAS BROKEN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24279301 ↗
• MalfunctionDec 12, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THE INSTRUMENT DOES NO LONGER HOLDS THE PINS. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23791421 ↗
• MalfunctionDec 8, 2025Corroded; Corroded

  IT WAS REPORTED THAT ATTUNE PIN PULLER WAS PITTING. THE ISSUE WAS OBSERVED DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THERE WAS NO FURTHER INFORMATION REGARDING THE ISSUE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23749647 ↗
• MalfunctionNov 14, 2025Break; Break

  IT WAS REPORTED THAT DEVICE WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23560575 ↗
• MalfunctionNov 14, 2025Break; Break

  IT WAS REPORTED THE DEVICES WERE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23555988 ↗
• MalfunctionNov 14, 2025Break; Break

  IT WAS REPORTED THE DEVICES WERE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23555976 ↗
• MalfunctionNov 14, 2025Break; Break

  IT WAS REPORTED THE DEVICES WERE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23555972 ↗
• MalfunctionNov 14, 2025Break; Break

  IT WAS REPORTED THE DEVICES WERE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23555912 ↗
• MalfunctionNov 6, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PIN JACK WAS NOT GRABBING UNIVERSAL SIGMA PINS. IT WAS REPORTED THAT THE USER OPENED A NEW PAN FOR THE PIN JACK. THERE WAS MINIMAL DELAY IN THE CASE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23487714 ↗
• MalfunctionNov 5, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING THE PROCEDURE THE DEVICE WAS NOT GRIPPING PINS. THERE WAS NO SURGICAL DELAY AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23480066 ↗
• MalfunctionOct 27, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PIN STUCK INSIDE THE JACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23390588 ↗
• MalfunctionSep 18, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A TOTAL KNEE PROSTHESIS SURGERY, THE PINS PULLER DID NOT SQUEEZE ENOUGH AND THERE WAS DIFFICULTY IN REMOVING PINS. THE PROCEDURE WAS NOT STOPPED AND THE SURGEON DID NOT CHANGE TECHNIQUE. THERE WAS A DELAY OF FIVE MINUTES IN SURGERY, AND THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23083751 ↗
• MalfunctionSep 16, 2025Device-Device Incompatibility; Device-Device Incompatibility

  WHEN USING THE EXTRACTOR TO REMOVE THE PINS, FORCE WAS APPLIED TO CLOSE THE CLAMP. HOWEVER, THE PIN DID NOT REACT. THE DEVICE WORKS FINE AT TIMES THEREFORE, IT WAS DECIDED TO CONTINUE USING THE MOTOR TO REMOVE THE PINS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23066345 ↗
• MalfunctionMay 29, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PIN JACK DOESN'T WORK. IT JUST SCRATCHES THE TIP OF THE PINS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22106221 ↗
• MalfunctionMay 21, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT ATTUNE PIN JACK WAS STICKING AND DID NOT WORK WITH MULTIPLE ATTACHMENTS PRIOR TO THE START OF THE CASE. THIS ISSUE DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22061223 ↗
• MalfunctionMay 19, 2025Structural Problem; Structural Problem

  IT WAS REPORTED THAT ONE OF THE SCREWS ON THE PIN JACK HAS COME LOOSE AND FALLEN OUT RENDERING THE PIN JACK UNUSABLE. THE EVENT DID NOT HAPPEN DURING A PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22043202 ↗
• MalfunctionApr 21, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT PIN DRIVER DOES NOT WORK ANYMORE. SURGICAL DELAY UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21872019 ↗
• MalfunctionMar 20, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PIN JACK WAS DEFECTIVE. IT WON'T CONSISTENTLY WORK NORMALLY. THERE WAS NO DELAY AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21653297 ↗
• MalfunctionMar 4, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT THERE WAS DIFFICULTY WITH PIN PULLER WHILE PULLING PINS. PIN PULLER WAS STICKING ACCORDING TO PA WHO USED IT. THE SURGICAL DELAY IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 21513381 ↗