Arthrex® AR-1677BC-CPRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867096066), received between Jun 5, 2017 and Mar 8, 2021 — classified as 3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 8, 2021Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED DURING A LIGAMENT RECONSTRUCTION/ TENDON INTERPOSITION (LRTI) OF THE THUMB, THE SURGEON WAS ATTEMPTING TO USE THE AR-1677BC-CP CMC LIGAMENT RECONSTRUCTION SYSTEM FOR THE FIRST TIME. THE SYSTEM DID NOT WORK THE WAY THE SURGEON HAD HOPED. THE SURGEON'S FIRST COMPLAINT WAS THAT THEY COULD NOT GET THE TENDON PASSER ((B)(6) FINGER TRAP) TO WORK. AFTER 10 WASTED MINUTES, THEY FINALLY GAVE UP AND USED A SUTURE TO SHUTTLE THE TENDON. THE SECOND COMPLAINT WAS THAT THE 4.0MM TENODESIS SCREW MALFUNCTIONED. THE SURGEON DRILLED 4.0MM TUNNEL AND PULLED THE TENDON THROUGH. BUT THE SCREW HAD NO BONE PURCHASE AND PULLED RIGHT OUT. THE SURGEON ATTEMPTED A SECOND TIME BUT WITH THE SAME RESULT. THE REP OFFERED A 4.75 TENODESIS AS A BACK UP BUT THE DOCTOR THOUGHT IT WOULD BE TOO BIG. INSTEAD THE SURGEON DRILLED SOME BONE TUNNELS AND TIED THE TENDON DOWN TO BONE. THE BONE QUALITY WAS SOFT.

  Patient problems: Insufficient Information

  MAUDE report 11436913 ↗
• InjuryAug 21, 2018Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2018 THE PATIENT UNDERWENT A CARPAL-META CARPAL FASCIA ARTHROPLASTY WITH LIGAMENT RECONSTRUCTION PROCEDURE WHERE A CMC LIGAMENT RECONSTRUCTION IMPLANT SYSTEM, AR-1677BC-CP, WAS IMPLANTED. ABOUT 5 WEEKS POST-OP, THE PATIENT BEGAN TO EXPERIENCE REDNESS AND SWELLING AT THE INCISION SITE. THE PATIENT WAS SEEN AT HIS SURGEON¿S OFFICE AND WAS PRESCRIBED IV ANTIBIOTICS AND WAS SCHEDULED FOR A DEBRIDEMENT. ON (B)(6) 2018, A SECOND SURGERY FOR DEBRIDEMENT WAS PERFORMED AND TO THIS DATE, THE PATIENT HASN¿T HAD ANY MORE SYMPTOMS. PATIENT IS A MALE.

  Patient problems: Erythema; Swelling

  MAUDE report 7800696 ↗
• InjuryOct 10, 2017Break; Detachment Of Device Component; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT DURING A CMC LIGAMENT RECONSTRUCTION CASE, AFTER THE SURGEON CUT THE FCR TENDON AND PLACED THE NEW TENDON THROUGH THE INCISION MADE AT THE DORSORADIAL ASPECT OF THE WRIST, HE DRILLED WITH THE GUIDE PIN INTO THE 1ST METACARPAL. HE THEN CONTINUED WITH THE CANNULATED DRILL. HE USED THE QUICKPASS TENDON SHUTTLE AND WAS SUCCESSFUL IN PASSING THE TENDON THROUGH THE NEWLY CREATED TUNNEL. THE 4MMX10MM TENODESIS SCREW, THAT'S INCLUDED IN THE CMC IMPLANT SYSTEM WAS THEN PLACED ON THE DRIVER AND HE ATTEMPTED TO PLACE THE SCREW AND TENDON INTO THE HOLE. HE ATTEMPTED TO ADVANCE THE SCREW INTO THE HOLE, BUT WAS UNSUCCESSFUL IN HIS FIRST ATTEMPT. HE RETRIED AND WAS STILL UNABLE TO ADVANCE THE SCREW. HE THEN NOTICED THE SCREW HAD BROKEN; THE THREADING ON THE SCREW CAME APART, AND THE FRONT HALF OF THE SCREW HAD BROKEN-OFF AND WAS LEFT IN THE PATIENT. HOWEVER, THE TENDON AND SCREW WERE NOT FLUSH. THE REMAINDER OF THE SCREW WAS STILL ATTACHED TO THE DRIVER AND YOU COULD VISIBLY SEE THE THREADING OF THE SCREW AND WHERE IT HAD BROKEN. A NEW KIT WAS OPENED UP TO COMPLETE THE PROCEDURE. THE REMAINS OF THE FIRST TENODESIS SCREW WERE UNABLE TO BE REMOVED DURING THE PROCEDURE. PATIENT

  Patient problems: No Code Available

  MAUDE report 6934410 ↗
• InjuryJun 5, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TIGHTROPE FIXATION ON HER RIGHT HAND IN (B)(6) OF 2016. PATIENT STATED THAT SINCE HER SURGERY HER INCISION SITE IS TAKING A VERY LONG TIME TO HEAL. IN THE LAST FEW WEEKS THE PATIENT HAS BEEN EXPERIENCING A BURNING SENSATION AROUND WHERE THE BUTTON WAS IMPLANTED. PATIENT REPORTS THAT SHE HAS BEEN EXPERIENCING REDNESS AND SWELLING AT THE SURGERY SITE. PATIENT REPORTS THAT SHE IS EXTREMELY ALLERGIC TO NICKEL AND HAS REQUESTED THE COMPOSITION INFORMATION FOR HER IMPLANT, WHICH HAS BEEN PROVIDED TO HER.

  Patient problems: Burning Sensation; Impaired Healing; Skin Discoloration; Swelling

  MAUDE report 6610450 ↗