Arthrex® AR-1662BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888867020566), received between Jun 27, 2017 and Jul 25, 2025 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 25, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 7/3/2025, A PATIENT REPORTED VIA PHONE THAT HE EXPERIENCED PAIN AND ONGOING SWELLING OF THE LEFT KNEE AFTER AN MCL RECONSTRUCTION PROCEDURE ON (B)(6) 2024, DURING WHICH AN UNKNOWN 5.5MM SWIVELOCK ANCHOR, AN UNKNOWN FIBERTAK ANCHOR, AND A CADAVERIC MCL LIGAMENT FOR THE GRAFT RECONSTRUCTION WERE IMPLANTED. IT COULD NOT BE CONFIRMED IF THE CADAVERIC MCL LIGAMENT WAS AN ARTHREX PRODUCT. THE PATIENT STARTED TO EXPERIENCE IMMENSE PAIN AFTER THE PROCEDURE AND SWELLING IN THE LEFT LEG AROUND THE KNEE AREA. THE SURGEON PROVIDED PAIN MEDICATION FOR 2 WEEKS. EVEN AFTER 7 MONTHS OF PHYSICAL THERAPY, THE KNEE CONTINUES TO RANDOMLY SWELL. THE PATIENT OBTAINED TWO SECOND OPINIONS AT THE SAME FACILITY AND WAS TOLD THESE SYMPTOMS WERE TO BE EXPECTED. THE PATIENT STATED THAT HE MAY SUE THE DOCTOR AND IS CONTEMPLATING A KNEE REPLACEMENT PROCEDURE. HE EXPERIENCES THE PAIN MOSTLY AROUND THE AREA WHERE THE SWIVELOCK ANCHOR WAS IMPLANTED AT THE TOP OF THE KNEE, NOT WHERE THE FIBERTAK ANCHOR WAS LOCATED AT THE BOTTOM OF THE KNEE. THE PATIENT IS LOOKING FOR THE MATERIAL COMPOSITION OF THE UNKNOWN IMPLANTS AND WILL UNDERGO ORTHOPEDIC ALLERGY TESTING. ON (B)(6) 2025, THE PATIENT PROVIDED THE FOLLOWING ADD

  Patient problems: Pain

  MAUDE report 22608986 ↗
• MalfunctionJul 21, 2025Material Frayed; Material Frayed

  ON 06/26/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1662BC SUTURE ANCHOR THREADS ARE STRIPPED. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22554876 ↗
• MalfunctionJul 21, 2025Material Frayed; Material Frayed

  ON 06/26/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1662BC SUTURE ANCHOR THREADS ARE STRIPPED. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22554875 ↗
• MalfunctionJul 21, 2025Material Frayed; Material Frayed

  ON 06/26/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1662BC SUTURE ANCHOR THREADS ARE STRIPPED. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22554873 ↗
• MalfunctionApr 23, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 02/21/2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1662BC BIOCOMPOSITE SWIVELOCK INSERTER COULD NOT BE PULLED OUT AND WHEN SURGEON WAS ABLE TO, THE ANCHOR PULLED OUT OF IMPLANTATION SITE AS WELL. SURGEON DRILLED AN ADDITIONAL BONE HOLE AND USED A NEW AR-1662BC BIOCOMPOSITE SWIVELOCK TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A RCR PROCEDURE ON 2/18/2022. NO FURTHER ISSUES HAS BEEN REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19163817 ↗
• MalfunctionJan 24, 2022Difficult to Insert; Material Deformation

  IT WAS REPORTED THAT DURING A BICEPS TENODESIS SURGERY THE DEVICE COULD NOT BE INSERTED COMPLETELY. AFTER SEVERAL ATTEMPTS TO FIX IT CORRECTLY WITH A SCREWDRIVER, IT WAS UNSCREWED AND IT WAS FOUND OUT THAT THE FRONT TIP OF THE ANCHOR WAS DEFECTIVE RESP. A SMALL PART WAS TORN OFF AND THEREFORE THE DEVICE COULD NOT BE INSERTED ANY FURTHER. THE DIVIDE WAS REMOVED AND A NEW ONE WAS USED WITHOUT PROBLEMS. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 13333812 ↗
• InjurySep 2, 2020Break

  IT WAS REPORTED DURING A BICEPS REPAIR PROCEDURE UPON INSERTING THE AR-1662BC SWIVELOCK BIOCOMPOSITE THE THREADS WERE DAMAGED. ADDITIONAL INFORMATION RECEIVED ON 8/17/2020: THE BONE WAS PREPPED BY DRILLING A 6.0MM LOPRO. AFTER THE ANCHOR FAILED, THE SURGEON DRILLED A 2.5 HOLE AND AN 8.0 LOPRO. THE SURGEON USED A 90 DEGREE STRAIGHT PASSER AND PASSED THE SUTURE THROUGH BOTH HOLES WHILE INSERTING THE TENDON INTO THE 8.0MM HOLE AND TIED THE SUTURE. THE IMPLANT WAS DISCARDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10482083 ↗
• InjuryJun 27, 2017Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A ROTATOR CUFF REPAIR ON (B)(6) 2017 WHERE A BIO-COMPOSITE SWIVELOCK TENODESIS SUTURE ANCHOR, AR-1662BC-7 ((B)(4)) WAS IMPLANTED INTO THE PATIENT'S SHOULDER. APPROXIMATELY FOUR DAYS AFTER THE SURGERY, THE PATIENT BEGAN TO EXPERIENCE TROUBLE BREATHING AND SWELLING IN THE THROAT. THE PATIENT HAS BEEN TREATED AT THE ER FOR SYMPTOMS. NO REDNESS OR SWELLING CAN BE SEEN AT THE SURGERY SITE. THE PATIENT CLAIMS THEY HAVE NEVER HAD ANY ISSUES OF THIS NATURE UNTIL AFTER THEIR PROCEDURE. THE PATIENT'S ONLY KNOWN ALLERGY IS PENICILLIN. THE BELOW PART NUMBERS WERE ALSO IMPLANTED ON (B)(6). AR-1662BC LOT 10110092 1EA ((B)(4)), AR-1927PSF LOT 10068319 1EA ((B)(4)), AR-1926PS LOT 10064848 1EA ((B)(4)) AND AR-1926PS LOT 10053400 1EA ((B)(4)).

  Patient problems: Dyspnea; Hypersensitivity/Allergic reaction; Swelling

  MAUDE report 6671308 ↗