NA 2299-90-025Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295115281), received between Aug 24, 2018 and Feb 13, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2026Structural Problem; Unintended Movement

  PINNACLE CUP IMPACTOR (OLD BRAIN LAB, DISCONTINUED) IS BROKEN. THE GRIP PART OF THE HANDLE SPINS FREELY AND DOESN¿T LOCK. MAKING VERY DIFFICULT TO POSITION THE CUP WHEN IMPLANTING. THE SURGEON USED THIS IMPACTOR WHEN HE USE TO USE BRAIN LAB AND WE KEPT IT BECAUSE HE REALLY LIKED THE LONGER LENGTH OF THE HANDLE. NEEDS TO BE REPLACED, I GUESS WITH A STANDARD PINNACLE IMPACTOR (2217-50-041). NOT FRAGMENTS OR BROKEN PIECES WERE CREATED. WHEN WE NOTICED, WE JUST OPENED ANOTHER SET AND USED A NEW IMPACTOR. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? --> UNKNOWN, WAS PROCEDURE SUCCESSFULLY COMPLETED? --> UNKNOWN, WERE FRAGMENTS GENERATED? --> UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? --> UNKNOWN, 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, IP-02659096 DEVICE PROPERTY OF -->HOSPITAL, DEVICE IN POSSESSION OF -->SPD BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24332731 ↗
• MalfunctionJan 20, 2026Unintended Movement

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGICAL PROCEDURE IT WAS OBSERVED THAT THE PINNACLE CUP IMPACTOR GRIP HANDLE WAS SPINNING INDEPENDENTLY FROM THE IMPACTOR ITSELF. IT WAS REPORTED THAT THE SURGEON USUALLY SPINS THE WHOLE IMPACTOR DURING CUP IMPLANTATION. HOWEVER, THIS TIME THE CUP WAS GRABBING, AND THE HANDLE OF IMPACTOR WAS JUST SPINNING. IT WAS REPORTED THAT THERE WERE NO BROKEN PIECES OR FRAGMENTS. IT WAS REPORTED THAT THERE WAS NO DELAY AS THE SURGEON WAS ABLE TO HOLD AND SPIN FROM THE SMALL END WHERE MALLETING IS PERFORMED. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT, OR SURGICAL DELAY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24116275 ↗
• MalfunctionDec 13, 2024Break; Break

  IT WAS REPORTED ON (B)(6) 2024, DURING AN ARTHROPLASTY PROCEDURE, THE CUP IMPACTOR TIP BROKE OFF THE CUP WHILE GETTING IMPACTED. SURGEONS HAD TO USE A NEEDLE DRIVER TO REMOVE THE THREADED TIP OF THE IMPACTOR FROM THE IMPLANT BEFORE IMPACTING THE LINER. THE IMPACTOR DID BREAK INTO TWO (2) PIECES, NO FRAGMENTS WERE GENERATED, AND ALL PIECES WERE REMOVED. THIS INCIDENT CAUSED A FIVE (5) MINUTE DELAY TO REMOVE THE THREADED TIP AND OPEN A SECOND IMPACTOR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20926649 ↗
• MalfunctionNov 15, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT THREADS ON INSERTER WERE DAMAGED.

  Patient problems: Insufficient Information

  MAUDE report 20699193 ↗
• MalfunctionJul 1, 2021Break; Break

  IT WAS REPORTED THAT THE HANDLE BROKE DURING IMPACTION, DID NOT DELAY OR AFFECT SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12099999 ↗
• MalfunctionMar 29, 2021Break; Break

  DURING THE CASE THE PINNACLE INSERTION HANDLE WAS BEING USED AND WHILE THE SURGEON WAS IMPLANTING THE CUP THE BACK ON THE HANDLE CAME OFF AND THE INSTRUMENT BROKE APART. NO FRAGMENTS WERE GENERATED ALL PIECES WERE RECOVERED AND DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11585785 ↗
• MalfunctionNov 19, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT UPON INSPECTION PRIOR TO USING IN SURGERY, IT WAS DISCOVERED THAT THE HANDLE SPINS AND DOES NOT ALLOW TO BE UNTHREADED FROM CUP. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9340913 ↗
• MalfunctionOct 25, 2019Break; Break

  PUT THREADED PIECE BACK IN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9241213 ↗
• MalfunctionAug 24, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT HANDLE SPINS, SMALL METAL HANDLE HOLDER FAULTY. BOX TRIAL STRIPPED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7813581 ↗