Arthrex® AR-1676DSRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867020801), received between May 17, 2017 and Nov 9, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionNov 9, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1676DS BIO-TENODESIS¿ DISPOSABLE KITS DRIVER TIP BROKE OFF INSIDE THE PATIENT. THIS OCCURRED DURING A FHL TENDON TRANSFER ON (B)(6) 2023, ONCE THE SURGEON HAD DRILLED THROUGH THE BONE THE DEVICE DID NOT LOOK RIGHT. THE END LOOKED SMALLER THAN NORMAL. AN X-RAY WAS TAKEN AND IT APPEARED AS IF THE EYELET WAS CUT OUT INTO THE TIP OF THE DRILL BIT THAT BROKE IN THE BONE. THE FRAGMENT REMAINS IN THE PATIENT. CASE WAS COMPLETED USING ANOTHER AR-1676DS BIO-TENODESIS¿ DISPOSABLE KIT.

  Patient problems: Foreign Body In Patient

  MAUDE report 18104095 ↗
• InjuryApr 4, 2019Break

  IT WAS DISCOVERED DURING MAUDE REVIEW (REPORT KEY (B)(4)) THAT THE FACILITY HAD SUBMITTED A MEDWATCH REPORT (B)(4) (WHICH HAS ALSO BEEN RECEIVED BY ARTHREX). FACILITY REPORTED THE FOLLOWING: ¿THE THREAD PROVIDED BY THE KIT TO WHIPSTITCH THE TENDON WAS SHORT. ANOTHER ONE WAS SUPPLIED AND USED TO PASS THROUGH THE METAL LOOP AT THE END OF THE DRIVER. THE METAL LOOP WAS BROKEN WHEN THE SCREW WAS INSERTED. A SECOND SCREW WAS DONE WITH THE SAME OUTCOME. THE TENDON WAS NOT DRIVEN IN.¿ UPON INVESTIGATION THE SALES REP, WHO WAS PRESENT DURING THE PROCEDURE, HAS PROVIDED THE FOLLOWING INFORMATION: SALES REP STATES HE HAD EXPRESSED THAT THE SURGEON NEEDED TO SIZE TO MAKE SURE THE TENDON WAS NOT LARGER THAN THE 3.5MM HOLE THAT WAS DRILLED. THE SURGEON CHOSE TO NOT SIZE THE TENDON PRIOR TO DRILLING THE 3/5MM HOLE. THE SURGEON PROCEEDED TO TRY TO PLUG THE TENDON INTO THE HOLE WITH A TENODESIS DRIVER AND THE SUTURE BROKE AT THIS TIME. REP FURTHER STATES THAT THE TENDON LENGTH WAS TOO SHORT TO ADVANCE IN THE BONE AND TENDON LENGTH WAS ALSO LARGER THAN THE SIZE DRILL SURGEON CHOSE TO USE WHICH MAY HAVE LED TO THE SUTURE BREAKING WHILE FORCING THE TENDON INTO THE BONE. REP ALSO INDICATED THAT SURGEO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8484020 ↗
• InjuryMay 17, 2017Break; Detachment Of Device Component

  IT WAS REPORTED THAT ON (B)(6) 2017, DURING A PROXIMAL BICEPS TENODESIS CASE, THE SURGEON WAS USING A DISPOSABLE INSTRUMENT KIT FOR TENODESIS SCREW. AFTER DISSECTING DOWN TO THE POINT ON THE HUMERUS WHERE HE WANTED TO PLACE THE REPAIR HE DRILLED AN ARTHREX 2.4 GUIDE PIN INTO THE SITE. THE GUIDE PIN CAME FROM THE DISPOSABLE INSTRUMENT KIT FOR TENODESIS SCREW (AR-1676DS). AFTER DRILLING THE GUIDE PIN, HE THEN OVER-REAMED WITH AN 8.5MM REAMER FROM AN ARTHREX BIO-TENODESIS SET. AFTER REAMING TO THE DESIRED DEPTH, PULLING THE DRILL OUT, AND DISMANTLING THE DRILL FROM POWER, THE SURGEON NOTICED THAT THE GUIDE PIN WAS MISSING. HE IMMEDIATELY PICKED UP THE REAMER AND LOOKED THROUGH THE CANNULATION TO DISCOVER THAT THE DRILL PIN WAS STILL STUCK INSIDE THE REAMER. HE THEN PLACED THE REAMER WITH THE PIN STUCK INSIDE OF IT BACK DOWN ON THE MAYO STAND. THE SURGEON WAS ABLE TO CREATE THE SOCKET AND SUBSEQUENTLY SCREW IN AN 8MM FORKED TIP SL TENO ANCHOR SUCCESSFULLY SECURING THE TENDON AND COMPLETING THE TENODESIS. AFTER THE SURGERY, IT WAS DISCOVERED THAT A PIECE OF THE GUIDE PIN BROKE-OFF AND WAS RETAINED INSIDE OF THE PATIENT. THE SURGEON WAS ABLE TO SUCCESSFULLY REMOVE THE RETAINED PORTION IN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6571650 ↗