ATTUNE 2545-00-742Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295134145), received between Aug 3, 2018 and Nov 11, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2025Break; Break

  IT WAS REPORTED THAT IMPACTED PRODUCTS WERE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23523001 ↗
• MalfunctionNov 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE INSTRUMENTS WERE MISSING SPRINGS, AND EASILY DISPLACED FROM THE ARCTIC SURFS. BROKEN INSTRUMENTS, HAPPENED DURING SURGERY BUT NO PATIENT AFFECTED, OR SURGERY DELAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23495980 ↗
• MalfunctionJan 11, 2024Break; Break

  ATTUNE SHIM SZ3 7MM IS CHIPPED AROUND THE RIGHT METAL RING. PATIENT STATUS/ OUTCOME / CONSEQUENCES: WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED? UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN. (B)(4). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. (B)(4). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. (B)(4). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. (B)(4). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. (B)(4). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18496889 ↗
• MalfunctionAug 16, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE DEVICE WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17555590 ↗
• MalfunctionApr 12, 2023Break; Break

  IT WAS REPORTED THE INSTRUMENT ARE BROKEN. THERE IS NO DESCRIPTION OF HOW THE DAMAGE OCCURRED OR THE EXTENT OF THE DAMAGE. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16728966 ↗
• MalfunctionApr 3, 2023Break; Crack; Scratched Material; Break; Crack; Scratched Material

  IT WAS REPORTED THAT THE DEVICE WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16663805 ↗
• MalfunctionJan 4, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE INSTRUMENTS ARE MISSING VARIOUS PARTS, INCLUDING THE SPRINGS, METAL RINGS, AND THE LOCK BUTTON DOESN'T WORK ON VARIOUS ITEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16095224 ↗
• MalfunctionJun 15, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE TRIAL WAS DEMOLISHED (BROKEN) WHILE TAKING IT OUT. NO DELAY DURING SURGERY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12003803 ↗
• MalfunctionAug 15, 2019Break; Material Deformation; Break; Material Deformation

  VARIOUS ATTUNE SHIMS FROM THE "SHIMS AND GENERAL INSTRUMENT" TRAY ARE SHOWING SIGNS OF WEAR, IN PARTICULAR CHIPPING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8897283 ↗
• MalfunctionJul 9, 2019Break; Break

  IT WAS REPORTED THAT THE SHIM WAS BROKE WHEN TAKING TRIAL POLY OUT AFTER CEMENTING. ALL PIECES WERE RETRIEVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8771023 ↗
• MalfunctionNov 2, 2018Break; Break

  IT WAS REPORTED THAT THE ATTUNE SHIMS CHIPPED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8032328 ↗
• MalfunctionSep 25, 2018Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT ATTUNE SHIMS CHIPPED AND DAMAGED FROM RETRACTORS IN SET.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7908402 ↗
• MalfunctionAug 3, 2018Scratched Material; Scratched Material

  IT WAS REPORTED THAT ATTUNE SHIMS CRACKED. FOUND DURING REP INSPECTION AND NOT DURING SURGERY. NO FURTHER INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7746374 ↗