ATTUNE 2506-10-112Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10603295436232), received between Sep 26, 2018 and Oct 21, 2024 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (14 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PIN GOT STUCK IN RIGHT TIBIA CUT BLOCK.

  Patient problems: Insufficient Information

  MAUDE report 20492412 ↗
• MalfunctionSep 16, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION STATES THAT DURING THE VISUAL EXAMINATION PERFORMED ON (B)(6) 2024, IT WAS FOUND THAT THE DEVICE (UNK FIXATION PIN) WAS JAMMED/SEIZED WITH THE TIBIAL BLOCK.

  Patient problems: Insufficient Information

  MAUDE report 20224904 ↗
• MalfunctionSep 12, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT A SMOOTH PIN GOT STUCK IN THE TIBIAL RESECTION PIN HOLE AND WON'T COME OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20199948 ↗
• MalfunctionJul 11, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT WHILE PUTTING PIN INTO THE ATTUNE RIGHT REVISION TIBIAL CUTTING JIG THE PIN STARTED GETTING COLD WELDED INTO THE CUTTING JIG. THE PIN COULDN'T BE REMOVED SO THE CUTTING JIG NEEDS TO BE REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 19720189 ↗
• MalfunctionMar 26, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PINS ARE STUCK IN TIBIAL CUTTING BLOCK. THE AUGMENT NO LONGER FITS INTO TRIAL. THE RP TRIAL POST IS BROKEN. UNKNOWN SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 18977423 ↗
• MalfunctionOct 31, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PIN GOT STUCK IN A TIBIA CUTTING BLOCK AND WON¿T COME OUT. THE PIN JACK BROKE TRYING TO REMOVE IT. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 18037515 ↗
• MalfunctionSep 29, 2023Material Deformation; Mechanical Jam; Material Deformation; Mechanical Jam

  DAMAGE TO CUTTING BLOCK, METAL SHARD STICKING OUT. THERE WAS NO PATIENT CONSEQUENCE OR SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17842423 ↗
• MalfunctionJun 6, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PIN GOT BOUND IN DRILL HOLE OF CUTTING BLOCK. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17073511 ↗
• MalfunctionMay 31, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT WHEN DRILLING A SMOOTH PIN INTO THE FIRST-STRAIGHT PINNING HOLE ON THE RIGHT TIBIAL CUTTING BLOCK THE PIN WAS GETTING STUCK AND SHAVING OFF METAL. AFTER THE CUT, THE SURGICAL TECH TRIED TO SLOWLY SLIDE A PIN IN THE SAME HOLE AND THE PIN WAS GETTING STUCK. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17032471 ↗
• MalfunctionDec 16, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PIN STUCK IN BLOCK AND NEEDS REPLACED. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15996433 ↗
• MalfunctionJul 14, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DRILL PIN GOT STUCK IN REVISION ATTUNE TIBIAL BLOCK RIGHT SIDE. THE DISPOSAL PIN IS STUCK IN THE BLOCK AND THE PACKAGING FOR THE DISPOSAL PIN WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12166555 ↗
• MalfunctionJun 28, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT TKA. DURING THE SURGERY, WHEN THE SURGEON FIXED THE PIN, IT INTERFERED WITH THE CUTTING GUIDE AND COULD NOT BE REMOVED.THE CAUSE WAS UNKNOWN. THE SURGERY WAS COMPLETED SUCCESSFULLY AND THERE WAS LESS THAN 30 MIN SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 12080555 ↗
• MalfunctionSep 17, 2020Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT THE PIN GOT STUCK IN A PIN HOLE DURING THE PROCEDURE AND COULD NOT BE REMOVED. HAD TO CUT BOTH ENDS OF THE PIN OFF AND LEAVE THE REST OF IT STUCK IN THE BLOCK IN ORDER TO PROCEED. NO SURGICAL DELAY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10546835 ↗
• MalfunctionAug 24, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT WHEN THEY WERE APPLYING THE PROXIMAL TIBIA CUTTING INSTRUMENT, ONE OF THE FIXATION PINS GOT STUCK IN THE PIN HOLE WHILE THEY WERE ATTEMPTING TO DRILL THE PIN INTO THE HOLE. THE MALLET HAD TO BE USED TO POUND THE PIN THROUGH THE HOLE. A NEW PIN WAS INSERTED INTO A DIFFERENT HOLE. A SURGICAL DELAY OF ONE TO TWO MINUTES.

  Patient problems: No Code Available

  MAUDE report 10442478 ↗
• MalfunctionOct 24, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DRILL IS STUCK ON GUIDE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9235925 ↗
• MalfunctionMay 14, 2019Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED THAT THE PIN BROKE OFF IN TIBIAL CUTTING BLOCK DURING PIN INSERTION. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8609634 ↗
• MalfunctionOct 15, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TIBIA CUTTING BLOCK WAS FOUND WITH A HEADED DRILL PIN STUCK AND BROKEN INSIDE A PIN HOLE BEFORE THE CASE STARTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7966512 ↗
• MalfunctionSep 26, 2018Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE ATTUNE THREADED PIN GOT STUCK IN ATTUNE REVISION TIBIAL CUTTING GUIDE. THE 5 MINUTES SURGICAL DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7909529 ↗