Arthrex® AR-1662BC-7Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867020573), received between Jun 27, 2017 and Sep 21, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 18, 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.

• MalfunctionSep 21, 2026Break

  On 7 Sep 2026, a distributor reported via email that one unit of AR-1662BC-7 SWVLK TENO BIO-COMP 7 × 19.5 mm Batch 15353573 experienced a deployment issue during a biceps repair procedure. During the procedure, the Tenodesis SwiveLock forked eyelet fractured after insertion on (b)(6) 2026. The anchor was initially inserted; however, the surgeon was not satisfied with the tensioning result and attempted to withdraw the anchor for adjustment. Upon removal, the forked eyelet was observed to be broken. A second anchor was subsequently provided and used to complete the repair. The pilot hole had been prepared using an AR-1408L instrument. No device fragments remained in the patient. The procedure was completed successfully using another SwiveLock device.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50843532 ↗
• MalfunctionMar 11, 2026Break

  ON 18-FEB-2026, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-1662BC-7 SWIVELOCK TENODESIS, BIOCOMPOSITE, 7 MM, WITH ONE SCREW, ONE FORK-TIP PEEK EYELET, AND ONE #2 FIBERWIRE SUTURE EXPERIENCED AN ISSUE DURING USE. THE TIP OF THE SCREW BROKE UPON CONTACT WITH THE BONE DURING IMPLANT INSERTION. NO FRAGMENTS REMAINED IN THE PATIENT. THE PROCEDURE WAS PERFORMED ON (B)(6) 2026 AND COMPLETED USING A REPLACEMENT AR-1662BC-7 ANCHOR. THERE WAS NO SIGNIFICANT SURGICAL DELAY, NO ADDITIONAL ANESTHESIA WAS ADMINISTERED, AND NO ADVERSE EFFECTS OR PATIENT HARM WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24567308 ↗
• MalfunctionSep 12, 2024Break; Break

  A PIECE DID BREAK OFF INSIDE THE PATIENT, BUT IT WAS RETRIEVED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20201338 ↗
• MalfunctionAug 24, 2021Break

  IT WAS REPORTED THAT A BIO-COMPOSITE TENODESIS SWIVELOCK, AR-1662BC-7, WAS BEING USED DURING A POSTERIOR MENISCAL PROCEDURE. UPON TAPPING THE SWIVELOCK INTO THE HOLE, THE FORK TIP BROKE OFF. THE IMPLANT WAS REMOVED AND THE TIP RETRIEVED FROM THE PATIENT. A SECOND BIO-COMPOSITE TENODESIS SWIVELOCK, AR-1662BC-7, WAS USED TO COMPLETE THE CASE WITHOUT FURTHER INCIDENT.

  Patient problems: Insufficient Information

  MAUDE report 12362247 ↗
• InjuryAug 23, 2018Loose or Intermittent Connection

  IT WAS REPORTED THAT THE ORIGINAL SURGERY TOOK PLACE (B)(6) 2015. ON (B)(6) 2015 WHEN PATIENT SAW THE SURGEON, HE NOTICED A LUMP WHERE LHBT (LONG HEAD OF THE BICEPS TENDON) WAS. ON (B)(6) 2015 A REVISION SURGERY WAS PERFORMED. THE SCREW CAME LOOSE AND ENDED UP RESTING IN THE DELTOID. THE BICEP HAD INTEGRATED INTO THE SOCKET. THE AR-1662BC-7 WAS REMOVED. IT WAS THEN SECURED WITH A BUTTON 10MM'S BELOW ORIGINAL DRILL HOLE. EXPLANTED DEVICE WAS DISPOSED OF. PROCEDURE WAS A PROXIMAL BICEPS. MALE PATIENT, AGE (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7808317 ↗
• 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 1 EA ((B)(4)), AR-1927PSF LOT 10068319 1 EA ((B)(4)), AR-1926PS LOT 10064848 1 EA ((B)(4)) AND AR-1926PS LOT 10053400 1 EA ((B)(4)).

  Patient problems: Respiratory Distress; Swelling

  MAUDE report 6671329 ↗