PINNACLE 2999-66-321Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295495048), received between Jan 5, 2018 and Oct 19, 2018 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 19, 2018Break; Break

  THE STRIKE PLATE ON END OF CUP IMPACTOR BROKE OFF THE SHAFT. ALL PARTS RETRIEVED. PATIENT CONSEQUENCE? NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7984440 ↗
• MalfunctionJan 8, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE MTO PINNACLE CUP IMPACTOR PN 299966321 HAD THE THREADED TIP COME LOOSE AND REMAIN IN THE CUP AFTER IMPLANTATION. THE TIP WAS REMOVED FROM THE CUP WITH MINOR DELAY LESS THAN 5 MINUTES AND NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7171384 ↗
• MalfunctionJan 8, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE MTO PINNACLE CUP IMPACTOR PN 299966321 HAD THE THREADED TIP COME LOOSE AND REMAIN IN THE CUP AFTER IMPLANTATION. THE TIP WAS REMOVED FROM THE CUP WITH MINOR DELAY LESS THAN 5 MINUTES AND NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7171381 ↗
• MalfunctionJan 5, 2018Dull, Blunt; Appropriate Device Problem Term/Code Not Available; Dull, Blunt; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE MTO PINNACLE CUP IMPACTOR WAS DISCOVERED AT WASH/STERILIZATION TO HAVE THE THREADED TIP INSERT EXTENDED FROM THE FACE OF THE HANDLE BY APPROXIMATELY 1MM. A SECOND HANDLE WAS FOUND WITH DAMAGED THREADS. BOTH OF THESE OCCURRED AFTER ON USE. INSERT RETAINING PIN APPEARS TO HAVE SHEARED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7167643 ↗
• MalfunctionJan 5, 2018Fracture; Fracture

  IT WAS REPORTED THAT THE MTO PINNACLE CUP IMPACTOR WAS DISCOVERED AT WASH/STERILIZATION TO HAVE THE THREADED TIP INSERT EXTENDED FROM THE FACE OF THE HANDLE BY APPROXIMATELY 1MM. A SECOND HANDLE WAS FOUND WITH DAMAGED THREADS. BOTH OF THESE OCCURRED AFTER ON USE. INSERT RETAINING PIN APPEARS TO HAVE SHEARED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7167624 ↗