Argo SPK475Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20845854649814), received between Aug 24, 2023 and Jul 9, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2025Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, SPK475, 4.75 MM ARGO KNOTLESS SP ANCHOR, WAS BEING USED DURING A ROTATOR CUFF PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿SURGEON INSERTED AND DEPLOYED IMPLANT AND THE METAL PORTION OF THE INSERTER REMAINED INSIDE THE ANCHOR. THE SURGEON WAS ABLE TO REMOVE THIS METAL PORTION WITH A SANP. SURGEON HAD TO USE A TOOL TO "YANK" BROKEN PART OUT OF THE PATIENT. PER SURGEON: "IT DONE BROKE".¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE USER OR PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT AN ALTERNATE DEVICE CAUSING A 5-MINUTE DELAY. 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 22456328 ↗
• MalfunctionDec 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, SPK475, 4.75 MM ARGO KNOTLESS SP ANCHOR, WAS BEING USED DURING A ROTATOR REPAIR PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿THE TITANIUM PART IS DISMANTLED BY CUTTING THE SUTURE OF THE DEVICE.¿. FURTHER ASSESSMENT FOUND THAT THERE WAS A DETACHMENT OF COMPONENTS THAT WAS RETRIEVED USING PLIERS AFTER X-RAY. THIS CAUSED A 3-HOUR DELAY IN THE PROCEDURE; HOWEVER, THE PROCEDURE WAS COMPLETED USING ANOTHER SPK475 DEVICE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. 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 20817553 ↗
• MalfunctionNov 18, 2024Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE SPK475, 4.75 MM ARGO KNOTLESS SP ANCHOR, DEVICE WAS BEING USED ON (B)(6) 2024 DURING A ROTATOR CUFF REPAIR PROCEDURE WHEN IT WAS REPORTED¿ THE ANCHOR BREAKS, THE PEEK FRAGMENT IS LOST INSIDE THE JOINT.". FURTHER ASSESSMENT QUESTIONING FOUND THAT ¿HE TRIED WITH SHAVER, WITH TWEEZERS AND FAILED TO REMOVE THE FRAGMENTS FROM THE JOINT. THE HOSPITAL HAS NOT REPORTED THE NOTIFICATION TO THE AUTHORITIES, AS I UNDERSTAND IT, BECAUSE THE FRAGMENT WAS SUCCESSFULLY REMOVED." ¿IT WAS ALSO REPORTED THAT "THEY KEPT THE FIRST IMPLANT; THE REST WAS REMOVED. "THE PROCEDURE WAS COMPLETED WITH A 3 HOUR DELAY AND THE USE OF THE SAME ALTERNATE DEVICE. THERE WAS NO REPORT OF MEDICAL INTERVENTION, EXTENDED HOSPITALIZATION FOR THE PATIENT. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS UNKNOWN. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20712196 ↗
• MalfunctionAug 24, 2023Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE SPK475, 4.75MM ARGO KNOTLESS SP ANCHOR, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED, ¿DIDN'T WORK AS SHOULD. METAL TIP FELL OFF INSIDE PATIENT. PIECE WAS RETRIEVED. SURGERY COMPLETED WITH A REGULAR K475.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED AS PLANNED WITH A SLIGHT DELAY WHILE RETRIEVING THE PIECE. 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 17610118 ↗