FASTIN ETHIBOND 222130Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886705007493), received between Jan 21, 2019 and Sep 12, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 12, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN UNKNOWN PROCEDURE OF THE ELBOW ON (B)(6) 2023, IT WAS OBSERVED THAT THE SUTURE DETACH FROM THE ANCHOR ON THE 3.0MM FASTIN® ANCHOR, SINGLE PACK DEVICE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17731558 ↗
• MalfunctionSep 12, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A REPAIR OF EXTERNAL ANKLE LIGAMENT. PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE SUTURE DETACH FROM THE ANCHOR ON THE 3.0MM FASTIN® ANCHOR, SINGLE PACK DEVICE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17731550 ↗
• MalfunctionMay 8, 2023Break; Break

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN UNKNOWN PROCEDURE OF THE ELBOW ON (B)(6) 2023, IT WAS OBSERVED THAT THE 3.0MM FASTIN® ANCHOR, SINGLE PACK DEVICE WAS BROKEN OFF WHEN TIGHTENED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16890494 ↗
• MalfunctionJan 21, 2019Material Frayed; Material Frayed

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE STRANDS OF FASTIN 3.0MM #2 ETH *EA SUTURE DEVICE SNAPPED. ACCORDING TO THE REPORTER, THE EVENT OCCURRED WHEN TENSIONING FOR THE FIRST KNOW WHEN IT WAS INSERTED INTO THE PATIENT'S ANCHOR BY HAND. IT WAS REPORTED THAT THE EVENT OCCURRED ONCE THE SURGEON WAS SATISFIED WITH THE DEPTH OF THE ANCHOR AND BEGAN TO TIE THE STRANDS INTO KNOT. IT WAS REPORTED THAT THE SURGEON WAS ABLE TO COMPLETE THE REPAIR USING LOOSE SUTURES. IT WAS REPORTED THAT THE SUTURE BROKE ABOVE THE ANCHOR JOINT AND NOT THE JOINT INTERFACE. IT WAS REPORTED THAT AFTER THE BREAKAGE, THE ANCHOR WAS LEFT IN THE PATIENT TO PREVENT ANY FURTHER DAMAGE TO THE BONE AND NO OTHER IMPLANTS WERE USED JUST A STAY SUTURE TO COMPLETE THE REPAIR. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 SUBMIT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8265002 ↗