ATTUNE 2544-00-111Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 10603295129943), received between Jun 20, 2018 and Sep 10, 2026 — classified as 4 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (26 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 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Device-Device Incompatibility

  It was reported that some pins would not fit in the pin driver, others were tight, and some were fine. It was unknown if there was a delay in surgery, successful completion of the surgery. There was no reported patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50713260 ↗
• MalfunctionSep 10, 2026Device-Device Incompatibility

  It was reported that some pins would not fit in the pin driver, others were tight, and some were fine. It was unknown if there was a delay in surgery, successful completion of the surgery. There was no reported patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50713243 ↗
• MalfunctionSep 10, 2026Device-Device Incompatibility

  It was reported that some pins would not fit in the pin driver, others were tight, and some were fine. It was unknown if there was a delay in surgery, successful completion of the surgery. There was no reported patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50713234 ↗
• MalfunctionSep 10, 2026Device-Device Incompatibility

  It was reported that some pins would not fit in the pin driver, others were tight, and some were fine. It was unknown if there was a delay in surgery, successful completion of the surgery. There was no reported patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50713222 ↗
• MalfunctionSep 10, 2026Device-Device Incompatibility

  It was reported that some pins would not fit in the pin driver, others were tight, and some were fine. It was unknown if there was a delay in surgery, successful completion of the surgery. There was no reported patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50713218 ↗
• MalfunctionSep 10, 2026Device-Device Incompatibility

  It was reported that some pins would not fit in the pin driver, others were tight, and some were fine. It was unknown if there was a delay in surgery, successful completion of the surgery. There was no reported patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50713215 ↗
• MalfunctionSep 10, 2026Device-Device Incompatibility

  It was reported that some pins would not fit in the pin driver, others were tight, and some were fine. It was unknown if there was a delay in surgery, successful completion of the surgery. There was no reported patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50713213 ↗
• MalfunctionSep 10, 2026Device-Device Incompatibility

  It was reported that some pins would not fit in the pin driver, others were tight, and some were fine. It was unknown if there was a delay in surgery, successful completion of the surgery. There was no reported patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50713182 ↗
• MalfunctionJun 25, 2026Device-Device Incompatibility

  IT WAS REPORTED THE PINS IN THE THREADED HEAD DID NOT FIT THE ATTUNE PIN DRIVER. A NEW PACK OF PINS WAS OPENED AND THEY FIT. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25618962 ↗
• MalfunctionJun 25, 2026Device-Device Incompatibility

  IT WAS REPORTED THE PINS IN THE THREADED HEAD DID NOT FIT THE ATTUNE PIN DRIVER. A NEW PACK OF PINS WAS OPENED AND THEY FIT. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25618958 ↗
• MalfunctionJun 23, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE PIN DRIVERS WERE RETAINING PINS IMPROPERLY CAUSING PINS TO PULL OUT AND STICK. AS A RESULT ONE PIN WAS COLD WELDED TO AN LEFT CUT BLOCK. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25598117 ↗
• MalfunctionJun 23, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE PIN DRIVERS WERE RETAINING PINS IMPROPERLY CAUSING PINS TO PULL OUT AND STICK. AS A RESULT, ONE PIN WAS COLD WELDED TO AN LEFT CUT BLOCK. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25598110 ↗
• MalfunctionApr 8, 2026Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SCREW SNAPPED INSIDE SCREW HOLE OF DISTAL CUTTING JIG, UNABLE TO GET THE SCREW OUT AND THE CUT WAS ALREADY MADE SO NO ADDITIONAL MEASURES HAD TO BE TAKEN. REPLACED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24816914 ↗
• MalfunctionSep 22, 2025Device-Device Incompatibility; Device-Device Incompatibility

  PATIENT UNDERWENT KNEE SURGERY ON (B)(6) 2025. INTRAOPERATIVELY, A PIN FROM THE ATTUNE PINNING SYSTEM REPEATEDLY GOT STUCK IN THE CUTTING BLOCKS (BENT, METAL NOSE, OR BOTH). OTHER PINS HAVE BEEN USED ON THE BLOCKS AND WORKED PERFECTLY WELL. THIS COMPLICATED THE SURGERY BUT HAD NO IMPACT ON THE OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23109643 ↗
• MalfunctionJan 8, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  THREADED HEADED ATTUNE PIN HEAD SNAPPED OFF INSIDE THE HP PIN DRIVER. IT WAS UNKNOWN IF THE SURGERY WAS COMPLETED SUCCESSFULLY OR DELAYED. IT WAS ALSO UNKNOWN IF THERE WERE FRAGMENTS GENERATED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21103147 ↗
• MalfunctionDec 13, 2024Break; Break

  IT WAS REPORTED THAT THE PIN BROKE OFF INTO TWO PARTS WHEN FIRST TIME IT WAS SCREWED INTO THE FEMUR. ALL PARTS HAVE BEEN RECOVERED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THERE WAS NO PATIENT HARM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20921912 ↗
• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6), STUDY NO: (B)(6). CLINICAL ADVERSE EVENTS RECEIVED FOR POSITIVE TISSUE BIOPSY X2 KNEE SYNOVIUM. DEVICE AND PROCEDURE (RELATEDNESS): DEVICE RELATED: DEFINITELY NOT, PROCEDURE RELATED: POSSIBLY, DATE OF EVENT: 15 JAN 2019, DATE OF IMPLANT: (B)(6) 2019, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: INJECTED MEDICATION.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 20507018 ↗
• MalfunctionJul 3, 2024Break; Break

  IT WAS REPORTED THAT BROKEN PIN WOULDN'T FREE FROM CUTTING BLOCK. CHECK AGAINST OTHER PINS ¿ THIS REVEALED THAT NONE OF THE PINS WOULD FIT CORRECTLY AND LIKELY THE METAL HOLE HAD PERHAPS WARPED OUT OF SHAPE AND WOULD NOT FUNCTION CORRECTLY. THE SAME PINS WERE COMPARED TO THE RIGHT CUTTING BLOCK ON THIS TRAY AND PERFORMED AS INTENDED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19664517 ↗
• MalfunctionJan 16, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  FIXATION PIN BROKE IN THE CUTTING BLOCK AND IS JAMMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18520035 ↗
• MalfunctionNov 30, 2023Break; Break

  TINY SHARDS OF ATTUNE THREADED PINS BROKE OFF INTO THE WOUND WHEN USING THE ATTUNE PS CUTTING BLOCKS DURING 2 X TOTAL KNEE REPLACEMENTS. SURGEON REMOVED THE FRAGMENTS FROM THE WOUND. SURGERY DELAYED LESS THAN 1 MINUTE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18236882 ↗
• MalfunctionNov 30, 2023Break; Break

  TINY SHARDS OF ATTUNE THREADED PINS BROKE OFF INTO THE WOUND WHEN USING THE ATTUNE PS CUTTING BLOCKS DURING 2 X TOTAL KNEE REPLACEMENTS. SURGEON REMOVED THE FRAGMENTS FROM THE WOUND. SURGERY DELAYED LESS THAN 1 MINUTE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18236880 ↗
• MalfunctionNov 29, 2023Break; Break

  TINY SHARDS OF ATTUNE THREADED PINS BROKE OFF INTO THE WOUND WHEN USING THE ATTUNE PS CUTTING BLOCKS DURING 2 X TOTAL KNEE REPLACEMENTS. SURGEON REMOVED THE FRAGMENTS FROM THE WOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18227127 ↗
• MalfunctionNov 29, 2023Break; Break

  TINY SHARDS OF ATTUNE THREADED PINS BROKE OFF INTO THE WOUND WHEN USING THE ATTUNE PS CUTTING BLOCKS DURING 2 X TOTAL KNEE REPLACEMENTS. SURGEON REMOVED THE FRAGMENTS FROM THE WOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18227108 ↗
• MalfunctionSep 5, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT INTRAOPERATIVELY THE PINS SEEMED TO BE TOO THICK AND DID NOT FIT. NO SURGICAL DELAY, NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17686352 ↗
• MalfunctionAug 7, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ONE OF THE PIN HOLES DID NOT FIT THE ATTUNE PINS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17469171 ↗