FDA Adverse Event
Malfunction
Summary report: N
BIORAPTOR KNOTLESS
MDR report key: 2902029
·
Received January 8, 2013
Report
- Report Number
- 1219602-2013-00009
- Event Type
- Malfunction
- Date Received
- January 8, 2013
- Date of Event
- December 13, 2012
- Report Date
- December 13, 2012
- Manufacturer
- MANSFIELD MANUFACTURING SITE
- Product Code
- MBI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS DISCARDED; NO EVALUATION POSSIBLE. (B)(4).
Description of Event or Problem · 1
IT WAS CONFIRMED THAT WHILE INSERTING THE ANCHOR INTO THE PATIENT'S HIP, THE DOCTOR POUNDED THE ANCHOR IN. UPON REMOVING THE DEVICE IT WAS VISUALIZED ON THE C-ARM THAT A PIECE OF METAL WAS IN THE BONE. THE DEVICE WAS THEN INSPECTED BY THE SALES REP AND ONE OF THE FORKS WAS CONFIRMED TO BE ABSENT FROM THE DEVICE. THE DOCTOR HAD NO INTENTION OF REMOVING THE METAL PIECE. THE DEVICE WAS DISCARDED POST-OP SO NO ITEMS WILL BE RETURNING FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 9361 | BIORAPTOR KNOTLESS | BIORAPTOR KNOTLESS SUTURE ANCH/HIP | MBI | MANSFIELD MANUFACTURING SITE | 72202397 | 50435188 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |