Arthrex® AR-1927BCNFRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867023406), received between Apr 27, 2018 and Jun 19, 2024 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2024Break; Break

  IT WAS REPORTED THAT DURING A CUFF REPAIR SURGERY THE TIP OF THE ANCHOR BROKE OFF. THE TIP BROKE INSIDE THE PATIENT BUT ALL PIECES WERE RETRIEVED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19568205 ↗
• MalfunctionJun 19, 2024Break; Break

  IT WAS REPORTED THAT DURING A CUFF REPAIR SURGERY THE TIP OF THE ANCHOR BROKE OFF. THE TIP BROKE INSIDE THE PATIENT BUT ALL PIECES WERE RETRIEVED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19568150 ↗
• MalfunctionOct 11, 2023Break; Break

  ON (B)(6) 2023, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT AN AR-1927BCNF BIOCOMPOSITE CORKSCREW FT BROKE INSIDE THE PATIENT'S FOOT. THE SURGEON SAFELY REMOVED THE FRAGMENTS. THIS WAS DISCOVERED DURING A RIGHT ANKLE ARTHROSCOPY PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Failure of Implant

  MAUDE report 17914789 ↗
• MalfunctionJul 27, 2021Break

  IT WAS REPORTED THAT DURING ROTATOR CUFF SURGERY THE ANCHOR DID BREAK OFF. THE BROKEN OFF PIECE HAS BEEN RETRIEVED FROM THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12231963 ↗
• InjuryJun 21, 2018Insufficient Device Problem Information

  IT WAS REPORTED BY A PATIENT THAT SHE HAD A HAMSTRING REPAIR PROCEDURE ON (B)(6) 2013. DURING THE PROCEDURE AN ARTHREX AR-1927BCNF, BIO-COMP CORKSCREW FT VENTED ANCHOR, LOT 538947 WAS IMPLANTED. PATIENT HAS HAD VARIOUS SYMPTOMS WHICH HAVE DEVELOPED OVER THE YEARS SINCE HER SURGERY. DURING THE PAST YEAR THE SYMPTOMS HAVE BECOME SEVERE. SYMPTOMS INCLUDE THE FOLLOWING: SEVERE DEBILITATING REACTIONS TO FOODS (IN PARTICULAR, THE LATEST TO THIS LIST IS SULFA FOODS; PATIENT CANNOT TOLERATE LOTIONS-SOAPS-ANY STRONG SMELLS (WHICH NOW INCLUDES PERFUMES); IMMEDIATE MIGRAINE HEADACHES AROUND CIGARETTE SMOKE; PATIENT HAS A RASH ON HER BACK THAT NO ONE IN MEDICAL WORLD HAS BEEN ABLE TO EXPLAIN (RASH BEGAN OCCURRING SOON AFTER THE SURGERY AND HAS NOW LASTED FOR YEARS); ADDITIONAL RASHES PRESENTING AS WELL WHICH ARE STAYING MORE PERMANENTLY NOW (THE LATEST BEING AROUND HER MOUTH). PATIENT STATES THE MIGRAINE HEADACHES ARE UNBEARABLE. PATIENT STATED SHE HAS BLOWN UNUSUAL AMOUNTS OF BLOOD OUT OF HER NOSE ON MANY OCCASIONS. PATIENT CONTINUALLY HAS LUNG AND BREATHING ISSUES. HER BODY TEMPS AS WELL AS BLOOD PRESSURE ARE ALWAYS LOW. EXTREMITIES (HANDS AND FEET) REMAIN COLD THE MAJORITY OF THE TIME. WITH

  Patient problems: Alteration In Body Temperature; Anxiety; Dizziness; Emotional Changes; Fatigue; Headache; Hypersensitivity/Allergic reaction; Inflammation; Low Blood Pressure/ Hypotension; Nausea; Rash; Sweating; Twitching

  MAUDE report 7625941 ↗
• InjuryApr 27, 2018Break; Detachment Of Device Component

  IT WAS REPORTED BY THE SALES REP THAT DURING A PATELLA TENDON RECONSTRUCTION PROCEDURE, AFTER THE SURGEON DRILLED THE PATIENT'S BONE, AS THE SURGEON WAS INSERTING THE TWO AR-1927BCNF BIOCOMPOSITE CORKSCREW ANCHORS (FT VENT 5.5 X 14.7 MM) THE ANCHORS BROKE. ABOUT 6 THREADS BROKE-OFF EACH, FLUSH (IF NOT A LITTLE COUNTERSUNK). THE EYELET AND SUTURES HELD IN PLACE AND THE INTERNAL BRACE HELD THE REPAIR. THE ANCHOR WAS SEATED AT 16.5 MM AND THE PATIENT'S BONE WAS VERY DENSE. A SUTURE TAPE WAS USED TO HELP PROTECT REPAIR IN CASE THE REMAINING PART OF THE ANCHOR EVENTUALLY MIGRATED OUT AND TWO INTERNAL BRACES WERE INCORPORATED TO AUGMENT THE REPAIR. PATIENT WAS A (B)(6). FOLLOW-UP INVESTIGATION: THE DISTAL PORTION OF THE ANCHORS WHICH REMAINED IN THE PATIENT ARE APPROXIMATELY 8 MM. THE PROXIMAL ENDS OF THE ANCHORS ARE NOT BEING RETURNED BECAUSE THEY WERE FRACTURED IN MULTIPLE PIECES (APPROXIMATELY 8 PIECES TOTAL) AND THROWN INTO THE BIOHAZARD BIN.

  Patient problems: Weight Changes

  MAUDE report 7467828 ↗