FDA Adverse Event
Malfunction
Summary report: N
VANGUARD PS BOX REAMER
MDR report key: 1222263
·
Received November 10, 2008
Report
- Report Number
- 1825034-2008-00288
- Event Type
- Malfunction
- Date Received
- November 10, 2008
- Date of Event
- October 8, 2008
- Report Date
- October 15, 2008
- Manufacturer
- BIOMET INC.
- Product Code
- HWE
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO USER FACILITY INFORMATION IS AVAILABLE.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 THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. EVALUATION OF DEVICE FOUND EVIDENCE THAT FAILURE MODE WAS DUE TO BENDING OVERLOAD.THIS REPORT FILED NOVEMBER 10, 2008.
Additional Manufacturer Narrative · 1
DEVICE MANUFACTURE DATE 11/15/2006
Description of Event or Problem · 1
UNK
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT UNDERWENT KNEE PROCEDURE IN 2008. DURING SURGERY, REAMERS FRACTURED WHILE IN USE. PATIENT IS REPORTED AS HAVING SCLEROTIC BONE. NO INJURY TO PATIENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VANGUARD PS BOX REAMER | INSTRUMENT, REAMER | HWE | BIOMET INC. | N/A | 473580 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |