OtherKGS
BIO-PUSHLOCK 3.5MM X 14MM
Received Sep 21, 2007 · Event occurred Jul 13, 2007
Report 1220246-2007-00196 · MDR key 979217
Device
Generic name
Bio-absorbable Implant
Manufacturer
Arthrex, Inc.Model number
NACatalog number
AR-1926B
Lot number
124287
Product problems
- Break
- Difficult to Insert
- Device, removal of (non-implant)
Patient
*
- Foreign body, removal of
Narrative
Description of Event or Problem
CUSTOMER REPORTS: THE DEVICE BROKE IN THE PT'S RIGHT SHOULDER WHILE IT WAS BEING IMPLANTED INTO THE GLENOID. THE LOOSE PIECES WERE RETRIEVED AND REMOVED ARTHROSCOPICALLY IN CONJUCTION WITH THE SCHEDULED PROCEDURE. FURTHER COMMUNICATION WITH THE HOSP INDICATES NO ADVERSE CONSEQUENCES WERE REPORTED WITH THE PT. THIS DEVICE IS USED FOR TREATMENT.
Additional Manufacturer Narrative
THE DEVICE HAS BEEN RETURNED AND INVESTIGATION IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.