PINNACLE 2218-40-156Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10603295101499), received between Jul 14, 2017 and Apr 21, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2026Break; Scratched Material

  IT WAS REPORTED THAT THE LINER TRIAL WAS SCRATCHED AND CHIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24939914 ↗
• MalfunctionNov 11, 2025Break; Break

  THIS IS REPORT 2 OF 3 OF (B)(4). IT WAS REPORTED THAT THAT ISSUES WERE NOTICED WITH SEVERAL DEVICES, AS FOLLOWS: EMPHASYS IMPACTOR: NORMAL WEAR AND TEAR. THE BIPOLAR HEAD TRIAL: NORMAL WEAR AND TEAR. THE SPACERBLOCK: BROKEN AND WAS MISSING A SPRING. THE LINER TRIAL: HAD A BROKEN TIP. CR FLEXION BASE: BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23526556 ↗
• MalfunctionJan 9, 2024Break; Break

  IT WAS REPORTED THAT THE TRIAL LINER 56 +4 10°X40ID BROKE AT APEX ,METAL SCREW PIECE FELL OUT, ALL PIECES RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18475810 ↗
• MalfunctionJun 12, 2023Break; Break

  IT WAS REPORTED THAT THE TRIAL WAS BROKEN. IT WAS OBSERVED TO BE BROKEN UPON OPENING THE TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17105123 ↗
• MalfunctionDec 12, 2022No Apparent Adverse Event; No Apparent Adverse Event

  THE INSTRUMENTS WAS REPORTED FOR UNKNOWN REASON. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15965061 ↗
• MalfunctionDec 12, 2022No Apparent Adverse Event; No Apparent Adverse Event

  THE INSTRUMENTS WAS REPORTED FOR UNKNOWN REASON. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15964211 ↗
• MalfunctionNov 16, 2022Break; Break

  LINER TRIAL BROKE WHILE REMOVING. ALL PIECES WERE RETRIEVED WITH NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15804106 ↗
• MalfunctionNov 30, 2021Break; Break

  IT WAS REPORTED THAT THE FOLLOWING INSTRUMENTS ARE DAMAGED AND NEEDS TO REPLACED. ALL PIECES WERE RETRIEVED FROM THE PATIENT. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12896054 ↗
• MalfunctionJun 11, 2021Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE LINERS APPEARS TO HAVE CRACKS AND SCRATCHES IN VARIOUS PLACES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11982358 ↗
• MalfunctionJun 11, 2021Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE LINERS APPEARS TO HAVE CRACKS AND SCRATCHES IN VARIOUS PLACES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11982312 ↗
• MalfunctionMay 5, 2021Crack; Scratched Material; Crack; Scratched Material

  IT WAS REPORTED THAT THE LINERS APPEARS TO HAVE CRACKS AND SCRATCHES IN VARIOUS PLACES. NO SURGICAL DELAYS OR PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11777658 ↗
• MalfunctionFeb 8, 2021Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT AFTER PUTTING SETS BACK TOGETHER THE INSTRUMENTS WERE FOUND BROKEN AND BENT. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11297735 ↗
• MalfunctionOct 20, 2020Break; Break

  IT WAS REPORTED THAT THE CALCAR PLANNER WAS DULL AND DOESN'T CUT WELL. PLEASE SEND REPLACEMENT SOS TO (B)(6) OFFICE, LINER TRIAL RING BROKEN. NO SURGICAL DELAY.

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

  MAUDE report 10706419 ↗
• MalfunctionMar 23, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE INSTRUMENTS WERE DAMAGED DURING SURGERY. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9865295 ↗
• MalfunctionFeb 12, 2020Break; Break

  BROKEN LINER TRIAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9701912 ↗
• MalfunctionDec 6, 2018Break; Break

  IT WAS REPORTED THAT THE SCREW PIECE HAS DETACHED FROM LINER TRIAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8136850 ↗
• MalfunctionOct 4, 2018Break; Break

  IT WAS REPORTED THAT THE LINERS TRIALS WERE BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7935927 ↗
• MalfunctionAug 8, 2018Component Missing; Component Missing

  IT WAS REPORTED THAT PIN TRL LNR + 4 10 DEG 401D 56OD (RING HOLDING METAL CENTERPIECE IN PLACE IS MISSING).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7761795 ↗
• MalfunctionDec 13, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SCREW PIECE OF LINER TRIAL HAS BECOME DETACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7112686 ↗
• MalfunctionJul 14, 2017Break; Break

  IT WAS REPORTED THAT THE IMPACTOR FITTING BROKE. IT WAS STATED THAT IT WAS DISCOVERED WHEN RETURNED TO THE OFFICE FOR INSPECTION.

  Patient problems: No Information

  MAUDE report 6713423 ↗