KINCISE 2999-66-455Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295511267), received between Aug 18, 2022 and Aug 15, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT IT WAS NOT FITTING INTO ANY KINCISE. THE EVENT DID NOT HAPPENED DURING A SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22818413 ↗
• MalfunctionJan 3, 2025Break; Break

  IT WAS REPORTED THAT THE SCREWDRIVER SNAPPED WHILE TRYING TO REMOVE IMPACTOR FROM COMP. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21069051 ↗
• MalfunctionNov 4, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY PATIENT CONSEQUENCE RELATED TO THE EVENT? NO CONSEQUENCE. B. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? NO DELAY. C. CAN YOU PLEASE CLARIFY WHAT DO YOU MEAN BY ¿DAMAGED¿? WAS IT WORN, CRACKED, BROKEN INTO PIECES, BENT, STRIPPED, CROSS THREADED OR ANY DEVICE INTERACTION. THREADS WERE STRIPPED.

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

  MAUDE report 20600144 ↗
• MalfunctionFeb 29, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT AS THE CUP WAS BEING INSERTED ONTO THE OFFSET INSERTER, THE TIP OF THE DRIVER BECAME STRIPED WHILE TIGHTENING THE CUP TO THE INSERTER. THE CASE WAS NOT DELAYED AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18807270 ↗
• MalfunctionJan 29, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT IS REPORTEDLY UNKNOWN IF THERE WAS ANY PROLONGING OF THE SURGICAL PROCEDURE. THERE IS NO INDICATION THAT THE DELAY RESULTED IN ANY IMPACT TO THE EXPECTED SURGICAL OUTCOME, OR RESULTED IN ANY PATIENT CONSEQUENCE OR INJURY.

  Patient problems: Insufficient Information

  MAUDE report 18595000 ↗
• MalfunctionOct 20, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE MTO KINCISE OFF CUP IMPACTOR DID NOT ENGAGE OR TIGHTEN DOWN IN A NORMAL MANNER. THERE WAS A CLICKING SOUND LIKE IT WAS CATCHING ON SOMETHING WHEN TIGHTENING DOWN WITH THE SCREW DRIVER. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES. IF YES, NUMBER OF MINUTES: 3. ACTION TAKEN WHEN EVENT OCCURRED? OPENED ANOTHER SET THAT HAD ANOTHER IDENTICAL PRODUCT. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? UNKNOWN. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN. OTHER INFORMATION: JUST SEEMED LIKE THE PRODUCT WAS STRIPPED OR OVERTIGHTENED BY THE SURGEON. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO. PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC? 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. (B)(4). DEVICE PROPERTY OF: OTHER. DEVICE IN POSSESSION OF: SALES CONSULTANT. 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17979008 ↗
• MalfunctionSep 7, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE CUP WOULD NOT STAY TIGHTENED ON THE IMPACTOR. THE CENTRAL SCREW SEEMED TO BE CROSS THREADED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17698623 ↗
• MalfunctionAug 18, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE KINCISE OFFSET CUP IMPACTOR DRIVER - BROKEN AND NEEDS REPLACED. IT IS UNKNOWN WHEN THE ISSUE WAS OBSERVED. IT IS UNKNOWN IF THERE IS PATIENT INVOLVEMENT. IT IS UNKNOWN IF REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION OCCURRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15248115 ↗