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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867020603), received between Nov 27, 2018 and May 21, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2019Loose or Intermittent Connection

  IT WAS REPORTED DURING AN INITIAL LABRAL AND SLAP REPAIR PROCEDURE, THE FOLLOWING ARTHREX PARTS WERE IMPLANTED ON (B)(6) 2017: AR-1662BCC-7 // LOT: 10153102. AR-2324BCC-2 // LOT: 10140067. AR-2923BC // LOT: 10140969. APPROXIMATELY A YEAR AFTER THE INITIAL PROCEDURE, THE PATIENT STARTED EXPERIENCING SEVERE PAIN AND LIMITED RANGE OF MOTION IN THEIR LEFT SHOULDER. THE SURGEON PERFORMED A REVISION LEFT SHOULDER SCOPE, LYSIS OF ADHESIONS AND REMOVAL OF LOOSE BODY PROCEDURE ON (B)(6) 2019. THE LOOSENED BICEP ANCHOR (AR-1662BCC-7 / LOT: 10153102) WAS RETRIEVED SHATTERED IN MULTIPLE SMALL PIECES, WHICH HAD DEBRIDED ADHESION'S ONTO THE PATIENT'S ROTATOR CUFF. THE PRIMARY AND REVISION PROCEDURE WERE PERFORMED AT THE SAME FACILITY BY THE SAME SURGEON. NO ADDITIONAL ARTHREX PARTS WERE IMPLANTED DURING THE REVISION PROCEDURE. THE FOLLOWING ARTHREX PARTS WERE EXPLANTED DURING THE REVISION PROCEDURE: AR-1662BCC-7 // LOT: 10153102. ADDITIONAL INFORMATION PROVIDED VIA MEDICAL RECORDS ON MAY 6, 2019: ACCORDING TO THE MEDICAL RECORDS PROVIDED THE PATIENT HAD CONTINUED PAIN FROM (B)(6) 2017 THROUGH (B)(6) 2018. THE PHYSICAL THERAPY RECORDS DATED (B)(6) 2017 STATED "SHOULDER IS A LITTLE SORE ON ARRIVAL

  Patient problems: Adhesion(s); Loss of Range of Motion; Pain

  MAUDE report 8627538 ↗
• InjuryNov 27, 2018Break; Material Fragmentation; Loose or Intermittent Connection; Device Slipped

  IT WAS REPORTED VIA FDA MEDWATCH LETTER (MW5080256) THAT A PATIENT UNDERWENT A TENODESIS SURGERY ON THEIR RIGHT SHOULDER ON (B)(6) 2017. THE FIBERLINK SUTURE WAS PASSED THROUGH THE TORN BICEPS TENDON AND THEN FED THROUGH THE EYELET OF AN ARTHREX SWIVELOCK ANCHOR AND SEATED INTO THE PILOT HOLE ON THE PROXIMAL HUMERUS. ELEVEN MONTHS POST-OP, THE PATIENT HAD A SUDDEN PAIN/SPASM IN THEIR RIGHT SHOULDER. IMAGING TESTS REVEALED NUMEROUS "LOOSE BODIES" IN THE FRONT AND BACK OF THE PATIENT'S SHOULDER JOINT. ON (B)(6) 2018, AN ARTHROSCOPIC PROCEDURE WAS PERFORMED FOR REMOVAL OF THE FOREIGN BODIES. THE BROKEN FRAGMENTS OF THE SCREW WERE REMOVED VIA THREE HOLES IN THE PATIENT'S SHOULDER. THE BICEPS TENDON WAS NOTED TO BE ABSENT. THE SCREW WAS UNSTABLE AND DEFECTIVE. SEVEN WEEKS POST-OP FROM THE SECOND SURGERY, THE PATIENT IS STILL EXPERIENCING SEVERE PAIN AND SPASMS WITH GREATLY DECREASED STRENGTH IN THE RIGHT ARM. NO FUNCTION TO BICEPS LONG HEAD DEFORMITY AND PERMANENT DEFORMITY. ADDITIONAL INFORMATION PROVIDED 11/15/2018: THE PATIENT HAS PROVIDED SCANNED ARTHROSCOPIC PHOTOS. THE SCANS SHOW THE ¿FOREIGN BODIES¿ FLOATING IN HER SHOULDER. THIS FAILED DEVICE HAS CAUSED HER BICEPS TO SLIP OFF TH

  Patient problems: Foreign Body In Patient; Muscle Spasm(s); Pain; Weakness

  MAUDE report 8107707 ↗