Arthrex® AR-8920CDSRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867048980), received between Apr 12, 2017 and Sep 16, 2024 — classified as 2 injuries, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2024Break; Break

  ON 08/26/2024, AN ARTHREX REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-8920CDS TIGHTROPE HAD AN ISSUE IN A CASE. THE TIGHTROPE WAS NOT COMPRESSING WITH THE LOOP. THE DEVICE PRESENTED PROBLEMS IN ITS REDUCTION, CAUSING ITS WIRES TO BREAK. THE REDUCTION OF ITS COMPONENTS WAS NOT BEHAVING AS EXPECTED. THE SURGEON USED ANOTHER DEVICE TO FINISH THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20224215 ↗
• InjuryMay 10, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  THE SISTER OF THE PATIENT CONTACTED ARTHREX ON (B)(6) 2017 REGARDING A REACTION AND PAIN OF AN ARTHREX IMPLANT IN THE PATIENT¿S KNEE. THE INCIDENT WAS INITIALLY ENTERED IN THE OLD ARTHREX COMPLAINT SYSTEM CREEKSIDE WITH REFERENCE NUMBER CC109970. A STATEMENT WAS PROVIDED BY THE SISTER OF THE AFFECTED PATIENT AND THE SURGEON WHICH SLIGHTLY DEVIATED FROM THE PROVIDED INFORMATION OF THE PATIENT¿S SISTER ON (B)(6) 2017. THE INFORMATION WAS INITIALLY PROVIDED AND DOCUMENTED IN CC109970 AND ARE DISPOSED IN THE NOTES OF THIS CASE. ON (B)(6) 2023 THE SISTER OF THE PATIENT CONTACTED ARTHREX AGAIN WITH THE FOLLOWING COMPLAINT. DUE TO ONGOING COMPLICATIONS, PAIN, STATE OF CONSTANT INFLAMMATION AND INFECTION THE PATIENT DECIDED TO REACH OUT TO A NEW SURGEON REQUESTING A REMOVAL OF THE IMPLANT. THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REMOVE THE IMPLANT ON (B)(6) 2017. THE SURGEON OF THE ADDITIONAL OPERATION DID NOT KNOW THE EXACT PLACEMENT OF THE IMPLANT, BECAUSE THE INFORMATION COULD NOT BE PROVIDED FROM THE FIRST SURGEON. IT IS NOT SURE IF ALL FRAGMENTS OF THE IMPLANT COULD BE RETRIEVED FROM THE KNEE, BUT THE CT SCAN AND ULTRASOUND ARE NOT SHOWING LEFT PIECES INSIDE THE PATIENT. TO THI

  Patient problems: Unspecified Infection

  MAUDE report 16906786 ↗
• InjuryApr 12, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016 THE PATIENT UNDERWENT A LEFT KNEE PROCEDURE, REPOSITION AND STABILIZATION OF TIBIOFIBULAR JOINT, IN POLAND, WHERE SHE RESIDES, DURING WHICH AN ARTHREX, AR-8920CDC, KNOTLESS TIGHTROPE SYNDESMOSIS REPAIR KIT WAS USED. PATIENT HAS BEEN EXPERIENCING CONTINUED PAIN, REDNESS, SWELLING AND REDUCED FLEXING ABILITY. PAIN HAS BEEN PRESENT IN THE INSIDE (RIGHT) PART OF THE KNEE BUT APPROXIMATELY 3 WEEKS PRIOR TO REPORTING PATIENT BEGAN FEELING PAIN ON THE OUTSIDE (LEFT) AND INSIDE OF THE KNEECAP TOO. KNEE FEELS HOT WHEN TOUCHED. PATIENT HAS HAD THREE REHABILITATION SESSIONS OF ONE WEEK TO TEN DAYS IN LENGTH, WHERE SHE WOULD STAY AT THE CLINIC, IN ADDITION TO HER REGULAR OUTPATIENT THERAPY SESSIONS. TO DATE PATIENT HAS HAD NO RELIEF FROM SYMPTOMS OR IMPROVEMENT WITH FLEXION. CALLER STATES SURGEON TOLD PATIENT IT IS NOT AN INFECTION, ALTHOUGH SEVERAL OTHER DOCTORS AND PHYSICAL THERAPIST HAVE TOLD PATIENT IT LOOKS LIKE AN INFECTION. IT WAS REPORTED SURGEON INFORMED PATIENT SHE WAS NOT DOING INTENSIVE ENOUGH THERAPY. SURGEON SENT HER TO A THERAPIST WHO PATIENT STATES OVER-BENT AND OVER STRETCHED HER LOG SO MUCH SHE WAS UNABLE TO STAND ON IT FOR ABOUT A WEEK. CA

  Patient problems: Alteration In Body Temperature; No Code Available; Pain; Swelling

  MAUDE report 6484935 ↗