inforMED
InjuryKGS

GII QUICKANCHOR W/ #2 ETHIBOND 5/BOX

Received Jul 9, 1999 · Event occurred Jun 15, 1999

Report 1221934-1999-00019 · MDR key 230944

Device

Generic name

Fastener, Fixation, Non-degradable Soft

Manufacturer

Mitek Products

Model number

212393

Catalog number

212393

Lot number

980616

Product problems

  • Device, or device fragments remain in patient
  • Suture line disruption

Patient

54 YR

  • Tissue Damage
  • Surgery, prolonged
  • Nonresorbable materials, unretrieved in body
  • Surgical procedure, additional

Narrative

Description of Event or Problem

AFTER ANCHORS' INSERTION, THE SUTURE ON ALL 3 BROKE WHILE DOCTOR WAS CHECKING RANGE OF MOTION. CASE FINISHED USING ALTERNATIVE OPEN PROCEDURE ANCHORS REMAIN IN PATIENT.