PINNACLE 2218-40-160Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295101512), received between Oct 12, 2017 and Mar 26, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THE INSTRUMENT WAS REPORTED FOR AN UNKNOWN REASON. DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21700141 ↗
• MalfunctionJul 1, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE PRODUCT WAS BROKEN.

  Patient problems: Insufficient Information

  MAUDE report 19643942 ↗
• MalfunctionJan 3, 2024Break; Break

  IT WAS REPORTED THAT THE TRIAL LINER IS BROKEN. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? UNKNOWN. DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? UNKNOWN. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO. 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. 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 18434809 ↗
• MalfunctionOct 27, 2021Break; Break

  NURSE REPORTED AN ATTUNE SPACER BLOCK MISSING A SPRING, REQUIRES REPLACEMENT. ALSO AN ATTUNE SIZE 3 TRIAL IS MISSING A SPRING AND REQUIRES REPLACEMENT. FINALLY A 40MM TRIAL LINER BROKE AND REQUIRES REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12708804 ↗
• MalfunctionMar 16, 2021Corroded; Material Twisted/Bent; Corroded; Material Twisted/Bent

  IT WAS REPORTED THAT THE INSTRUMENTS WERE REPORTED DUE TO CORROSION AND WEAR. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11497398 ↗
• MalfunctionSep 9, 2020Break; Crack; Break; Crack

  IT WAS REPORTED THAT THE 40X60 +4 10 LINER TRIAL WAS BROKEN DURING TRIALING. THE PLASTIC AROUND THE METAL SCREW WAS CRACKED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10508761 ↗
• MalfunctionMar 23, 2020Break; Break

  IT WAS REPORTED THAT AFTER INSERTING THE CUP HE ATTEMPTED TO SCREW THE TRIAL LINER AND THE RING CAME OFF, THEN THE BOLT AND PLASTIC TRIAL LINER CAME APART. HE WAS ABLE TO RETRIEVE ALL PIECES. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9868293 ↗
• MalfunctionMay 7, 2019Break; Break

  IT WAS REPORTED THAT THE LINER TRIAL WAS BROKE AT 10DEG +4 40ID 60 OD . NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8588285 ↗
• MalfunctionMar 1, 2018Break; Break

  IT WAS REPORTED THAT THE TWO LINER TRIALS AND ESC REMOVAL TOOLS WERE BROKEN DURING SURGERY. ALL PIECES RETRIEVED FROM THE PATIENT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7307394 ↗
• MalfunctionOct 12, 2017Break; Break

  IT WAS REPORTED THAT THE CENTRAL SCREW ADAPTER IN TWO ES3 LINER TRIALS BROKE.

  Patient problems: No Information

  MAUDE report 6944314 ↗