HALL PRIMECUT SH127-090-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20845854083335), received between Dec 16, 2024 and Dec 16, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2024Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, SH127-090-25, HALL PRIMECUT CASSETTE, 1.27 X 090 X 25 MM, WAS BEING USED DURING A TKR PROCEDURE ON 12NOV24 WHEN IT WAS REPORTED, ¿A TOOTH OF THE PRIMECUT SAW BLADE BROKE OFF DURING THE CASE, UNABLE TO FIND AND THIS IS THE SECOND TIME IT HAS HAPPENED. PT X-RAYED POST IMPLANTATION OF PROTHESIS, NO SAW BLADE VISIBLE. PATIENT X-RAYED TO DETERMINE IF FRAGMENT IF SAW BLADE WAS RETAINED IN THE WOUND. X-RAY CONFIRMED THAT THE SAW BLADE TOOTH WAS NOT IN THE PATIENT'S SURGICAL WOUND.". THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THE PROCEDURE WAS COMPLETED AS PLANNED. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20937609 ↗