FASTIN ORTHOCORDRecalls & reported problems across all models

We found 4 models of FASTIN ORTHOCORD by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 73 adverse event reports in the FDA's MAUDE database, received between Jul 3, 2017 and Sep 21, 2026 — classified as 6 injuries, 67 malfunctions.

The most frequently reported specific device problem is “Break” (31 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported FASTIN ORTHOCORD problems

FASTIN ORTHOCORD models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• FASTIN ORTHOCORD 222993

  Screw, fixation, bone
  35 reports
• FASTIN ORTHOCORD 222991

  FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
  30 reports
• FASTIN ORTHOCORD 222994

  Screw, fixation, bone
  5 reports
• FASTIN ORTHOCORD 222992

  Screw, fixation, bone
  3 reports

Recent FASTIN ORTHOCORD adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50846571 ↗
• MalfunctionSep 16, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50788470 ↗
• MalfunctionApr 21, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE UNKNOWN PROCEDURE, THE FASTIN RC 5.0 W/OCORD W/NDLS ANCHOR WAS HANDED TO THE SPECIALIST, AND UPON IMPACT AND SUBSEQUENT THREADING, THE GUIDE ON WHICH THE ANCHOR WAS MOUNTED WAS WITHDRAWN; HOWEVER, THE ATTACHED SUPER-SUTURES WERE FOUND TO BE BROKEN AND TORN, CAUSING THE ANCHOR TO DETACH AND REMAIN LODGED WITHIN THE PATIENT'S BONE, RENDERING THE TITANIUM ANCHOR UNRECOVERABLE. TO RESOLVE THIS ISSUE, A PEEK ANCHOR WAS PROVIDED TO THE PHYSICIAN, ALLOWING THE PROCEDURE TO BE COMPLETED CORRECTLY AND THE SURGERY TO CONCLUDE SUCCESSFULLY. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT, NOR WERE THERE ANY ALTERATIONS TO THE SURGICAL TIMELINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24942385 ↗
• MalfunctionAug 14, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE SURGEON INSERTED THE ANCHOR ON THE FASTIN RC 5.0 W/OCORD W/NDLS DEVICE, IT HIT THE TIP AND THREAD ALIGNED WITH THE SECOND LASER LINE. WHEN ATTEMPTING TO KNOT THE TWO SUTURES THAT WERE PART OF THE ANCHOR, THE SURGEON OBSERVED THAT ONE OF THE SUTURES BROKE. AS A RESULT, IT WAS IMPOSSIBLE TO COMPLETE THE FIXATION SINCE THE ANCHOR WAS DESIGNED TO INCLUDE TWO SUTURES, BUT ONLY ONE REMAINED USABLE. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22809746 ↗
• MalfunctionJul 31, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE FASTIN RC 5.0 W/OCORD W/NDLS DEVICE, WHEN THE ANCHOR WAS IMPLANTED IN THE PATIENT, NOTED SUTURE WAS DETACHED FROM ANCHOR. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22674056 ↗
• MalfunctionJul 16, 2025Break; Mechanical Problem; Appropriate Device Problem Term/Code Not Available; Break; Mechanical Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE ANCHOR ON THE FASTIN RC 5.0 W/OCORD W/NDLS DEVICE WAS FOUND TO BE BROKEN. ACCORDING TO THE REPORTER, WHILE THE SURGEON WAS INSERTING THE FASTIN ANCHOR, STRAIN WAS LOST WHEN PASSING THROUGH THE TISSUE ¿(M.R.)¿, CAUSING THE ANCHOR TO BECOME MISALIGNED OR LOOSENED FROM THE TIP OF THE HANDLE. THE SURGEON ATTEMPTED TO REPOSITION THE ANCHOR BACK IN THE HANDLE, BUT WHEN TRYING TO PASS IT THROUGH THE TISSUE AGAIN, THE TENSION IN THE THREADS WAS LOST. THE SURGEON INDICATED THAT THE ANCHOR DID NOT GRIP PROPERLY, AND WHEN REMOVING THE HANDLE FROM THE ANCHOR, THE ENTIRE SUTURE CAME OUT WITH IT, LEAVING THE ANCHOR IN PLACE WHILE THE THREADS WERE COMPLETELY CUT. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22523357 ↗
• MalfunctionJul 10, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT WHEN THE SURGEON ATTEMPTED TO INSERT THE FASTIN RC 6.5MM OCORD W/O NDLS ANCHOR DEVICE, THE DEVICE COULD NOT BE INSERTED. A NEW DEVICE WAS USED AND WAS INSERTED WITH NO DIFFICULTY. THERE WAS NO HARM TO THE PATIENT AND NO SURGICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22468751 ↗
• MalfunctionJun 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, IT WAS OBSERVED THAT WHEN THE FASTIN RC 5.0 W/OCORD W/NDLS DEVICE ANCHOR WAS IMPLANTED IN THE PATIENT, THE SUTURE WAS DETACHED FROM ANCHOR. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22148401 ↗
• MalfunctionMay 29, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER STABILIZATION PROCEDURE IT WAS OBSERVED THAT THE FASTIN RC 5MM OCORD W/O NDLS ANCHOR INSERTER DID NOT RELEASE FROM THE ROD, EVEN WHEN USING THE CORRECT TECHNIQUE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT, OR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22107659 ↗
• MalfunctionMay 28, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT WHEN OPENING THE FASTIN RC 5.0 W/OCORD W/NDLS DEVICE IT WAS OBSERVED THAT THERE WAS A HAIR INSIDE THE PACKAGING. THEREFORE THE DEVICE WAS NOT REMOVED FROM THE PACKAGING. IT WAS UNKNOWN WHEN THE ISSUE OCCURRED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22096462 ↗
• MalfunctionMay 6, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT THE FASTIN RC 5.0 W/OCORD W/NDLS DEVICE ANCHOR WAS BENT, REMOVED THE ANCHOR FROM PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21967170 ↗
• MalfunctionApr 30, 2025Break; Break

  IT WAS REPORTED THAT WHEN TIGHTENING THE FASTIN RC 5.0 W/OCORD W/NDLS DEVICE ANCHOR A SCREWDRIVER WAS BROKEN, WHICH MADE IT IMPOSSIBLE TO INTRODUCE THE ANCHOR. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21935751 ↗
• MalfunctionApr 1, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A LABRAL TEAR REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE FASTIN RC 5MM OCORD W/O NDLS DEVICE ANCHOR DID NOT DETACH CORRECTLY FROM THE ROD WHEN TRYING TO FIX THE ANCHOR IN THE PATIENT'S SHOULDER MAKING IT IMPOSSIBLE TO ANCHOR IT IN THE BONE STRUCTURE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS AN UNSPECIFIED DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21737393 ↗
• MalfunctionMar 19, 2025Migration; Migration

  IT WAS REPORTED THAT DURING AN ORTHOPEDIC PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR ON THE FASTIN RC 5.0 W/OCORD W/NDLS DEVICE PULLED OUT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21643284 ↗
• MalfunctionFeb 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE WHILE USING FASTIN RC 5.0 W/OCORD W/NDLS DEVICE THE SUTURE FELL APART FROM THE ANCHOR AND THE ANCHOR COULD NOT BE REMOVED. THE DEVICE WAS USED WITH THE 4.75 HEALIX ADVANCE KNTLS PEEK AND THE HEALIX ALL-IN-ONE AWL DEVICE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS EVENT 1 OF 2 OF THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21424788 ↗

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