InjuryKGS
DEPUY MITEK FULLY ABSORABLE ANCHORS
Received Jun 9, 2005 · Event occurred Mar 21, 2005
Report 1221934-2005-00091 · MDR key 612432
Device
Generic name
Soft Tissue Fixation Device
Manufacturer
Depuy MitekModel number
*Catalog number
210625
Lot number
1265143
Product problems
- Explanted
- Tip breakage
Patient
43 YR
- Surgical procedure
- Foreign body, removal of
Narrative
Description of Event or Problem
THE INSERTER TIP HAD BROKEN OFF INTO THE PT SHOULDER DURING THE ORIGINAL SURGERY IN 2005. IT WAS DISCOVERED IN THE X-RAY'S TAKEN IN ABOUT 2 MONTHS LATER AND REPORTED TO THE AFFILIATE. A SECOND SURGERY WAS NECESSARY TO TAKE OUT THE PIECE. NO ADVERSE EFFECTS ARE BEING REPORTED AT THIS TIME.