MalfunctionKGS
HARPOON SUTURE ANCHOR
Received Dec 15, 2006 · Event occurred Nov 16, 2006
Report 1825034-2006-00130 · MDR key 798160
Device
Product problems
- Detachment Of Device Component
- Difficult to Insert
- Replace
- Other (for use when an appropriate device code cannot be identified)
Patient
UNKNOWN
- Unknown (for use when the patient's condition is not known)
- Surgical procedure
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING CARPECTOMY PROCEDURE, SUTURES DETACHED FROM TWO ANCHORS DURING ATTEMPTED INSERTION. ALTERNATE PRODUCT WAS USED TO COMPLETE THE PROCEDURE.
Additional Manufacturer Narrative
CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE BEEN NO TRENDS IDENTIFIED RELATED TO THIS TYPE OF EVENT.