Argo Knotless K4755RSPRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30653405988353), received between Mar 30, 2023 and Mar 30, 2023 — 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.

• MalfunctionMar 30, 2023Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER AGAINST THE REPORTED DEVICE, K4755RSP, 4.75/5.5 MM ARGO KNOTLESS REUSABLE SMOOTH PUNCH, WAS BEING USED DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED, ¿I HAD A SURGEON WHO USED THE K4755RSP FOR A ROTATOR CUFF REPAIR. WHEN HE BEGAN TO MALLET THE PUNCH INTO THE BONE A SLIVER OF METAL CAME OFF INSIDE THE JOINT. WHEN WE REMOVED THE PUNCH, IT LOOKED COMPLETELY FINE SO I CAN'T REALLY BE SURE AS TO WHY THIS HAPPENED OTHER THAN MAYBE SOME LEFTOVER MATERIAL WAS ON THE TIP OF THE PUNCH FROM MANUFACTURING?¿. A SERIES OF ASSESSMENT QUESTIONS WERE SENT AND IT WAS REPORTED THE DEVICE DID FRAGMENT BUT IT WAS RETRIEVED WITH THE SHAVER SUCTION. THERE WAS A REPORTED DELAY OF A FEW MINUTES AND ANOTHER PUNCH WAS USED TO COMPLETE THE SURGERY. THERE WAS NO REPORT OF PATIENT OR USER IMPACT, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16642062 ↗