GII ETHIBOND 212450Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886705002061), received between Jul 10, 2018 and Jan 24, 2020 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 24, 2020Break; Break

  IT WAS REPORTED BY THE AFFILIATE VIA COMPLAINT SUBMISSION TOOL THAT DURING AN UNKNOWN PROCEDURE THE GII EASY ARTHRO #2 ETH *EA WAS FOUND TO BE BROKEN BEFORE USING IT. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9629849 ↗
• MalfunctionJan 23, 2019Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  THIS IS REPORT 1 OF 3 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THREE ANCHORS WHERE THE SUTURE FRETTED AND BROKE UNDER MINIMAL TENSION IN A G2 ANCHOR. IT WAS REPORTED THAT TWO HAD BEEN SWITCHED OUT FOR ORTHOCORD. IT WAS REPORTED THAT THE ANCHORS WERE BEING USED TO 'SHUTTLE' THE DISTAL BICEPS TENDON DOWN HAVING BEEN WHIP STITCHED BY ONE LIMB OF SUTURE. ACCORDING TO THE REPORTER, THE SUTURES FRAYED ON A 'SHARP EDGE' AT THE ISLET. IT WAS REPORTED THAT THE PROCEDURE WAS EXTENDED BY 15 MINUTES. THERE WAS NO PATIENT HARM AS FURTHER ANCHORS WERE PLACED INTO THE SAME DRILL HOLES TO SECURE THE TENDON. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8270294 ↗
• MalfunctionJan 23, 2019Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  THIS IS REPORT 2 OF 3 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THREE ANCHORS WHERE THE SUTURE FRETTED AND BROKE UNDER MINIMAL TENSION IN A G2 ANCHOR. IT WAS REPORTED THAT TWO HAD BEEN SWITCHED OUT FOR ORTHOCORD. IT WAS REPORTED THAT THE ANCHORS WERE BEING USED TO 'SHUTTLE' THE DISTAL BICEPS TENDON DOWN HAVING BEEN WHIP STITCHED BY ONE LIMB OF SUTURE. ACCORDING TO THE REPORTER, THE SUTURES FRAYED ON A 'SHARP EDGE' AT THE ISLET. IT WAS REPORTED THAT THE PROCEDURE WAS EXTENDED BY 15 MINUTES. THERE WAS NO PATIENT HARM AS FURTHER ANCHORS WERE PLACED INTO THE SAME DRILL HOLES TO SECURE THE TENDON. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8270287 ↗
• MalfunctionJan 23, 2019Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  THIS IS REPORT 3 OF 3 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THREE ANCHORS WHERE THE SUTURE FRETTED AND BROKE UNDER MINIMAL TENSION IN A G2 ANCHOR. IT WAS REPORTED THAT TWO HAD BEEN SWITCHED OUT FOR ORTHOCORD. IT WAS REPORTED THAT THE ANCHORS WERE BEING USED TO 'SHUTTLE' THE DISTAL BICEPS TENDON DOWN HAVING BEEN WHIP STITCHED BY ONE LIMB OF SUTURE. ACCORDING TO THE REPORTER, THE SUTURES FRAYED ON A 'SHARP EDGE' AT THE ISLET. IT WAS REPORTED THAT THE PROCEDURE WAS EXTENDED BY 15 MINUTES. THERE WAS NO PATIENT HARM AS FURTHER ANCHORS WERE PLACED INTO THE SAME DRILL HOLES TO SECURE THE TENDON. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8270285 ↗
• MalfunctionJul 29, 2018Break; Break

  THE SALES REP REPORTED DURING A SHOULDER PROCEDURE, AFTER THE CUSTOMER'S GII ANCHOR WAS INSERTED, THE SUTURE BROKE WHILE BEING TENSIONED. THE SURGEON REMOVED THE ANCHOR AND USED ANOTHER LIKE DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE WAS EXTENDED ABOUT 10 MINUTES. THE FACILITY DISCARDED THE DEVICE. THE SALES REP WAS NOT PRESENT AT THE CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7730263 ↗
• MalfunctionJul 10, 2018Break; Break

  THE ADMINISTRATOR REPORTED THAT THE REPRESENTATIVE WAS NOTIFIED THAT DURING A ROTATOR CUFF REPAIR (RCR) YESTERDAY, THE FIRST TWO ANCHORS THEY ATTEMPTED TO USE HAD SUTURES SNAP ON THEM. THE CASE WAS FINISHED USING ANOTHER ANCHOR BUT UNDER DURESS AS THERE WAS LITTLE ROOM TO PLACE ANOTHER ANCHOR. THE FIRST TWO (2) ANCHORS REMAIN IN THE PATIENT. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-51251.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7673623 ↗
• MalfunctionJul 10, 2018Break; Break

  THE ADMINISTRATOR REPORTED THAT THE REPRESENTATIVE WAS NOTIFIED THAT DURING A ROTATOR CUFF REPAIR (RCR) YESTERDAY, THE FIRST TWO ANCHORS THEY ATTEMPTED TO USE HAD SUTURES SNAP ON THEM. THE CASE WAS FINISHED USING ANOTHER ANCHOR BUT UNDER DURESS AS THERE WAS LITTLE ROOM TO PLACE ANOTHER ANCHOR. THE FIRST TWO (2) ANCHORS REMAIN IN THE PATIENT. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-51252.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7673621 ↗