6.5MM ALLTHREAD TITANIUM SUTURE ANCHOR
Received Jan 7, 2009 · Event occurred Nov 5, 2008
Report 2027970-2008-00039 · MDR key 1281651
Device
Product problems
- Detachment Of Device Component
- Device, removal of (non-implant)
Patient
UNK
- Surgery, prolonged
- Foreign body, removal of
Narrative
Description of Event or Problem
WHILE INSERTING THE ANCHOR, IT BECAME DETACHED FROM THE HANDLE INSERTER. THE SURGEON WAS FORCED TO GO FROM AN ARTHROSCOPIC PROCEDURE TO A MINI-OPEN IN ORDER TO RETRIEVE THE ANCHOR. THIS CAUSED THE CASE TO BE EXTENDED APPROXIMATELY 1 HOUR.
Additional Manufacturer Narrative
EVALUATION SUMMARY: THE INVESTIGATION REVEALED THAT THE PUNCH TECHNIQUE WAS USED PRIOR TO INSERTING THE IMPLANT. ALLTHREAD TITANIUM SUTURE ANCHORS REQUIRE PRE-DRILLING PRIOR TO INSERTION. THE PUNCH TECHNIQUE APPEARS TO HAVE FRACTURED THE IMPLANT AND DRIVER AT THE MALE TO FEMALE HEX. UPON EXCESSIVE TORQUE, THE FRACTURE WEAKENED AND BROKE. PACKAGE INSERT WARNING # 8 STATES; DO NOT USE EXCESSIVE FORCE WHEN INSERTING THE ANCHOR. EXCESSIVE FORCE (E.G. LONG HARD HAMMER BLOWS) MAY CAUSE FRACTURE OR BENDING OF THE DEVICE. PRIOR TO INSERTION OF THE IMPLANT, PREDRILL, AWL OR TAP.