HYBRID GLENOID INSTRUMENT DRILL GUIDE ALIGNMENT PIN
Received Jun 19, 2012 · Event occurred May 21, 2012
Report 0001825034-2012-00876 · MDR key 2621058
Device
Generic name
Prosthesis, Shoulder
Manufacturer
Biomet OrthopedicsModel number
N/ACatalog number
406180
Lot number
304100
Product problems
- Improper or Incorrect Procedure or Method
Patient
Not reported
- Device Embedded In Tissue or Plaque
Narrative
Description of Event or Problem
IT WAS REPORTED PATIENT UNDERWENT TOTAL SHOULDER ARTHROPLASTY ON (B)(6), 2012. SUBSEQUENTLY, DURING THE POST-OPERATIVE X-RAYS, IT WAS DISCOVERED THE HYBRID GLENOID DRILL GUIDE ALIGNMENT PIN WAS LEFT INSIDE OF THE PATIENT.
Additional Manufacturer Narrative
CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT FOR RELATED IMPLANTS THAT STATES THAT THIS TYPE OF EVENT CAN OCCUR: UNDER PRECAUTIONS IT STATES, "INTRAOPERATIVE FRACTURE OR BREAKING OF INSTRUMENTS HAS BEEN REPORTED. SURGICAL INSTRUMENTS ARE SUBJECT TO WEAR WITH NORMAL USAGE. INSTRUMENTS, WHICH HAVE EXPERIENCED EXTENSIVE USE OR EXCESSIVE FORCE, ARE SUSCEPTIBLE TO FRACTURE. SURGICAL INSTRUMENTS SHOULD ONLY BE USED FOR THEIR INTENDED PURPOSE. BIOMET RECOMMENDS THAT ALL INSTRUMENTS BE REGULARLY INSPECTED FOR WEAR AND DISFIGUREMENT." THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(6), 2012. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO THE FDA.