GRYPHON PERMACORD 223149Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886705024742), received between Jan 23, 2023 and Jan 23, 2023 — classified as 1 malfunction.

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. 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.

• MalfunctionJan 23, 2023Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED BY SALES REP THAT DURING A SHOULDER ARTHROSCOPY LABRAL REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE HANDLE DISENGAGED FROM THE SHAFT INSERTER WHILE ATTEMPTING TO PULL OUT THE INSERTER ON THE GRYPHON¿ PEEK DS ANCHOR WITH PERMACORD¿SIZE 2, 36" DEVICE AFTER FASTENING THE ANCHOR INTO BONE. DURING IN-HOUSE ENGINEERING EVALUATION OF A PHOTO PROVIDED BY THE CUSTOMER, IT WAS DETERMINED THAT THE DISTAL TIP OF THE DEVICE SHAFT WAS DEFORMED; AND THE ANCHOR WAS NOT IN THE INSERTER. THEY USED A KOCKER AND MALLET TO DISENGAGE THE SHAFT FROM THE ANCHOR. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16226408 ↗