FAST-FIX AB ASSEMBLY - CURVED
Received Jun 25, 2009 · Event occurred May 28, 2009
Report 1219602-2009-00194 · MDR key 1478693
Device
Generic name
Fast-fix Ab Assembly - Curved/kgs
Manufacturer
Mansfiled Manufacturing SiteModel number
7209399Catalog number
7209399
Lot number
50265534
Product problems
- Break
- Device, or device fragments remain in patient
Patient
Not reported
- Unknown (for use when the patient's condition is not known)
Narrative
Additional Manufacturer Narrative
DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. (B) (4).
Description of Event or Problem
DURING SURGERY, THE IMPLANT STAYED IN THE PATIENT, BUT THE SUTURE BROKE. THE IMPLANTS WERE ALL LEFT IN THE BODY, EACH FAILURE OCCURRED AT THE POINT THE SURGEON PULLED TO TIGHTEN THE KNOT PRIOR TO PUTTING THE PUSHER CUTTER IN THE KNEE. THIS WAS AN EXPERIENCED SURGEON WHO SUCCESSFULLY PUT 6 FAST-FIX IN THE SAME PERSON. THE FAILURE OCCURRED RIGHT AT THE TO, WHEN PULLED, THE SUTURE BROKE A THE TO AND LEFT THEM BOTH IN KNEE FOR EACH OF THE 3 FAILURES. BACK UP DEVICES WERE ON HAND.