Arthrex® AR-1662S-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867096028), received between Feb 11, 2020 and Oct 19, 2020 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 19, 2020Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED DURING A BICEPS TENODESIS PROCEDURE THE AR-1662S-1 IMPLANT SYSTEM WAS BEING USED. UPON USING THE REAMER TO DRILL THE HUMERAL HEAD THE DEVICE WAS NOT DRILLING EFFICIENTLY, AND THE SURGEON HAD TO APPLY MORE PRESSURE THAN USUAL TO CREATE THE SOCKET. ONCE THE REAMER FINALLY STARTED PUNCTURING THE BONE AND DRILLING, THE SURGEON HAD DIFFICULTY STOPPING THE DEVICE FAST ENOUGH. THE PATIENT CAME BACK TO THE SURGEON A SHORT TIME AFTER THE SURGERY COMPLAINING OF PAIN AT THE SURGICAL SITE. X-RAYS WERE TAKEN AND IT WAS DISCOVERED THAT THE REAMER HAD DRILLED ALL THE WAY THROUGH THE CORTEX. THE PATIENT HAD TO UNDERGO A SECOND SURGERY IN WHICH NON ARTHREX PLATE AND SCREWS WERE IMPLANTED TO FIX THE ISSUE. ADDITIONAL INFORMATION OBTAINED 10/1/2020: THE ORIGINAL SURGERY DATE WAS (B)(6) 2020. THE PATIENT WAS SEEN FOR A FOLLOW UP ON (B)(6) 2020 DUE TO PAIN IN SHOULDER. AN X-RAY REVEALED A FRACTURE ON THE POSTERIOR CORTEX. THE PATIENT WAS TAKEN BACK TO SURGERY ON (B)(6) 2020 AND A PLATE AND SCREW WAS USED TO REDUCE AN STABILIZE THE FRACTURE AND THE 5.5 SWIVELOCK WAS REMOVED FROM THE PATIENT.

  Patient problems: Bone Fracture(s); Failure of Implant; Pain

  MAUDE report 10698344 ↗
• InjuryFeb 11, 2020Break

  IT WAS REPORTED DURING A SUBPEC BICEPS TENODESIS PROCEDURE THE SURGEON WAS USING THE AR-1662S-1 BICEPS TENODESIS IMPLANT SYSTEM. UPON INSERTING THE SWIVELOCK, THE SWIVELOCK BROKE IN HALF. THE REP REPORTED THE SURGEON REMOVED THE BROKEN PORTION OF THE IMPLANT, AND TUGGED ON THE SUTURE TO TEST FIXATION OF THE REMAINING SWIVELOCK THAT WAS REMAINED IN THE TUNNEL. THE REMAINING PORTION OF THE SWIVELOCK PROVED TO BE SECURE AND WAS HOLDING THE TENDON IN THE DRILL HOLE. THE SURGEON WAS CONTENT WITH THE OUTCOME OF THE REPAIR AND THE CASE WAS COMPLETED. THE RETRIEVED BROKEN PORTION OF THE SWIVELOCK WAS DISCARDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9693142 ↗