PINNACLE 2217-00-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10603295097235), received between Aug 28, 2018 and May 21, 2026 — classified as 43 malfunctions.

The most frequently reported specific device problem is “Break” (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 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2026Break

  IT WAS REPORTED THAT THE PINNACE SUCTION CUP INSERTER WAS BROKEN AND WORN. THERE WAS NO PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY IN SURGERY. THE LOT NUMBER WAS NOT AVAILABLE AND THE DEVICE WAS THROWN OUT AND THEREFORE, NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25246733 ↗
• MalfunctionDec 23, 2025Device-Device Incompatibility; Device-Device Incompatibility

  THE SUCTION CUP ON THE INSERT HOLDER IS DEFECTIVE; IT NO LONGER STAYS ON THE HANDLE AND CAN NO LONGER PROPERLY HOLD (SUCTION) AND INSERT AFTER THE EQUIPMENT HAS BEEN STERILIZED. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? NO. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? NO. PATIENT STATUS/ OUTCOME / CONSEQUENCES NO. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: NO. IS THE PATIENT PART OF A CLINICAL STUDY: NO. IP, (B)(6). 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 23877199 ↗
• MalfunctionJul 31, 2025Break; Break

  IT WAS REPORTED THAT THE PLASTIC PIECE AT THE TIP OF THE INSTRUMENT IS RIPPED. AN ALTERNATE BEARING SUCTION CUP INSERTER WAS USED. THE EVENT DID NOT HAPPEN DURING A SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22680015 ↗
• MalfunctionJul 24, 2025Break; Break

  IT WAS REPORTED THAT THE INSTRUMENTS WERE FOUND WITHIN A BROKEN INSTRUMENTS TUB AT HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22588623 ↗
• MalfunctionApr 29, 2025Break; Break

  IT WAS REPORTED THAT THE SUCTION END OF THE INSERTER SPLIT IN TWO. THERE WAS NO DELAY TO CASE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21925458 ↗
• MalfunctionOct 7, 2024Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT DURING SURGERY, THE PLASTIC TIP/INSERT SUCTION CUP WAS DAMAGED. IT WAS WORN, STRIPPED AND DID NOT WORK ITS PURPOSE. THERE WAS A SURGICAL DELAY BECAUSE THE SURGEON HAD TO SWITCH TO ANOTHER TOOL THAT HE DISLIKED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20383451 ↗
• MalfunctionSep 4, 2024Break; Unintended Movement; Break; Unintended Movement

  IT WAS REPORTED THAT THE SILICON SUCTION TIP CAME OFF IN STERILIZATION PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20136102 ↗
• MalfunctionSep 4, 2024Break; Unintended Movement; Break; Unintended Movement

  IT WAS REPORTED THAT THE SILICON SUCTION TIP CAME OFF IN STERILIZATION PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20136100 ↗
• MalfunctionAug 18, 2024Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  SUCTION CUP ON INSERT HOLDER IS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19999339 ↗
• MalfunctionJun 19, 2024Break; Break

  IT WAS REPORTED THAT THE SUCTION CUP INSERTER FOUND BROKE INTO 2 PIECES. ALL FRAGMENTS WERE REMOVED. NO PATIENT HARM. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19566872 ↗
• MalfunctionJan 16, 2024Break; Break

  IT WAS REPORTED THAT THE SUCTION CUP IS TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18519965 ↗
• MalfunctionJan 16, 2024Break; Break

  IT WAS REPORTED THAT THE SUCTION CUP IS TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18518501 ↗
• MalfunctionJan 3, 2024Break; Break

  IT WAS REPORTED THAT THE SUCTION CUP FROM INSERTION HANDLE IS MISSING. IT HAPPENED BETWEEN DECONTAMINATION AND CLEAN SIDE OF CENTRAL STERILE, NOT IN SURGERY. NO ADVERSE CONSEQUENCES, AND NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18440934 ↗
• MalfunctionFeb 28, 2023Break; Break

  THE INSTRUMENTS WERE REPORTED FOR UNKNOWN REASON. DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16451422 ↗
• MalfunctionJan 24, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THE INSTRUMENTS ARE WORN. DISCOVERY MADE BY STERILIZATION. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16233834 ↗
• MalfunctionDec 7, 2022Break; Naturally Worn; Break; Naturally Worn

  WEAR AND TEAR BREAKAGE OF INSERT INSERTER - NO LONGER USABLE FOR SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15934379 ↗
• MalfunctionDec 6, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT BOX OSTEOTOME IS DULL AND JAGGED. SUCTION CUP DOESN¿T STICK. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15924317 ↗
• MalfunctionDec 2, 2022Break; Break

  IT WAS REPORTED THAT THE AB SUCTION CUP INSERTER TIP BROKE OFF OF THE HANDLE. THE HANDLE WAS BEING RETURNED. NO CASE TIME ADDED TO AS A RESULT. PATIENT OUTCOME NOT INPACTED. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15902413 ↗
• MalfunctionNov 8, 2022Break; Break

  IT WAS REPORTED THAT THE SUCTION CUP RIPPED IN WASH. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15756104 ↗
• MalfunctionJul 25, 2022Break; Break

  IT WAS REPORTED THAT THE INSTRUMENTS ON THE PINNACLE INSTRUMENT SET BROKE. NO HARM TO THE PATIENT AND NO DELAY TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15094700 ↗
• MalfunctionApr 5, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE ACETABULAR LINER SUCTION CUP WILL NOT HOLD LINER ANYMORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14013223 ↗
• MalfunctionMar 2, 2022Break; Break

  IT WAS REPORTED THAT THE CERAMIC SUCCION CUP INSERTER (221700020) HAS BROKEN AND DOESN¿T SUCCION ANYMORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13651616 ↗
• MalfunctionFeb 22, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THESE INSTRUMENTS ARE BEING REPORTED FOR NATURAL WEAR AND TEAR. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13577109 ↗
• MalfunctionFeb 3, 2022Break; Break

  IT WAS REPORTED THAT THE RUBBER SUCKER FOR THE EXTRACTOR HAS A SPLIT IN IT. NEEDS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13440425 ↗
• MalfunctionSep 24, 2021Break; Break

  THE STRIKE PLATE END OF THE HANDLE IS BROKEN OFF AND NEEDS TO BE REPLACED. IF OTHER, DESCRIBE: WAS NOTIFIED THROUGH MDRD DURING STERILIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12528448 ↗