FDA Adverse Event
Malfunction
Summary report: N
HIP PAC, DISPOSABLE
MDR report key: 1635644
·
Received March 10, 2010
Report
- Report Number
- 1219602-2010-00046
- Event Type
- Malfunction
- Date Received
- March 10, 2010
- Date of Event
- February 10, 2010
- Report Date
- February 10, 2010
- Manufacturer
- MANSFIELD MANUFACTURING SITE
- Product Code
- NBH
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE IS NOT BEING RETURNED FOR EVALUATION. (B) (4)
Description of Event or Problem · 1
GUIDE WIRE USED TO LOCATE JOINT CAPSULE FOR ARTHROSCOPY. THE GUIDE WIRE BROKE OFF AT APPROXIMATELY 3 CM FROM THE END WHEN THE SPINAL NEEDLE WAS INSERTED INTO HIP OVER THE TOP OF THE WIRE. VISIBLE UNDER IMAGE INTENSIFICATION. GUIDE WIRE PIECE UNABLE TO BE REMOVED, AS IT COULD NOT BE LOCATED. PATIENT UNDERWENT FURTHER RADIOLOGICAL INVESTIGATION POST-OPERATIVELY, AND RETURNED TO THEATRE THE FOLLOWING DAY FOR SUCCESSFUL REMOVAL OF THE GUIDE WIRE PIECE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HIP PAC, DISPOSABLE | HIP PAC, DISPOSABLE / NBH | NBH | MANSFIELD MANUFACTURING SITE | 7209874 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |