Arthrex® AR-1662BC-8Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867020580), received between Mar 24, 2017 and May 10, 2021 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionMay 10, 2021Break

  IT WAS REPORTED THAT THE AR-1662BC-8 TIP WAS BROKEN WHEN A SCREW WAS INSERTED AND MALLETING WAS PERFORMED. ALL THE BROKEN PIECES HAVE BEEN RETRIEVED. BONE HOLE WAS MADE WITH AN 8 MM DIAMETER DRILL. ADDITIONAL BONE HOLES WERE CREATED AND SURGERY WAS COMPLETED USING A THIRD-PARTY PRODUCT.

  Patient problems: Insufficient Information

  MAUDE report 11802129 ↗
• InjuryDec 12, 2017Insufficient Device Problem Information

  IT WAS REPORTED BY PATIENT THAT SHE HAD UNDERGONE A PROCEDURE ON (B)(6) 2017 FOR RIGHT ROTATOR CUFF REPAIR, BICEP TENODESIS AND AC JOINT DECOMPRESSION. DURING THE PROCEDURE PATIENT RECEIVED SWIVELOCK ANCHORS AND BIO-TENODESIS SCREW IMPLANTS. SINCE SURGERY THE PATIENT HAS EXPERIENCED UNUSUAL SWELLING, WITH HER BICEPS BEING APPROXIMATELY DOUBLE ITS NORMAL SIZE. PATIENT IS ALSO EXPERIENCING THE FOLLOWING SINCE SURGERY: PAIN IN HER SHOULDER THAT IS DIFFERENT FROM THE TYPE OF PAIN EXPERIENCED PRIOR TO THE SURGERY AND AN UPPER BODY RASH THAT APPEARS TO RUN ALONG HER LYMPH NODE SYSTEM. PATIENT HAS HAD LYMPHATIC DRAINAGE MASSAGES TO TRY AND ALLEVIATE HER SYMPTOMS WITH NO SUCCESS. PATIENT MENTIONED THAT SHE SUFFERS FROM CELIAC, IS ALLERGIC TO MANY FOODS AND IS ALSO ALLERGIC TO COSTUME JEWELRY (NON-GOLD). PATIENT ALSO STATED THAT SHE HAS HAD PAST REACTION TO DENTAL IMPLANTS WHICH CAUSED EXTENSIVE WORK ONCE THE DEVICE WAS DETERMINED TO BE CAUSING THE PROBLEMS. PATIENT HAS REQUESTED THE MATERIAL COMPOSITION OF HER IMPLANTS TO HELP DETERMINE IF THERE IS A COMPONENT THAT MAY BE CAUSING HER ISSUES. ADDITIONAL INFORMATION OBTAINED 11/21/2017: DURING THE (B)(6) 2017 SURGERY THE PATIENT RECEIVED THE

  Patient problems: Pain; Rash; Swelling

  MAUDE report 7108020 ↗
• InjuryMar 24, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A BICEPS TENODESIS, THE ANCHOR PULLED OUT WHEN THE SURGEON WAS TYING THE FIBERWIRES OVER THE ANCHOR. AN 8.5 MM REAMER (AR-1455) HAD BEEN USED PRIOR TO INSERTION. DUE TO TENDON DAMAGE CAUSED BY THE ANCHOR COMING OUT, THE PROCEDURE WAS SWITCHED TO A TENOTOMY. ADDITIONAL INFORMATION OBTAINED 3/14/2017- THE TENDON WAS FRAYED AND TORN DUE TO THE ANCHOR COMING OUT.

  Patient problems: Tissue Damage

  MAUDE report 6431369 ↗