FDA Adverse Event
Malfunction
Summary report: N
ELITE PASS NEEDLES
MDR report key: 2508029
·
Received March 28, 2012
Report
- Report Number
- 1219602-2012-00071
- Event Type
- Malfunction
- Date Received
- March 28, 2012
- Date of Event
- February 28, 2012
- Report Date
- February 29, 2012
- Manufacturer
- SMITH & NEPHEW MANSFIELD MANUFACTURING SITE
- Product Code
- HWQ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION. (B)(4).
Description of Event or Problem · 1
DURING SHOULDER PROCEDURE, THE DISTAL TIP OF THE SHUTTLE NEEDLE BROKE OFF. THEY COULD NOT LOCATE IT. THE DR. TOOK A SECOND NEEDLE TO FINISH THE CASE. THE DR. COULD NOT LOCATE THE DISTAL TIP OF THE NEEDLE THAT BROKE OFF. THEY DID NOT TAKE AN X-RAY AFTER THE PROCEDURE TO LOOK FOR THE MISSING PIECE. IT WAS STATED THE DR. DIDN'T FEEL IT WAS NECESSARY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ELITE PASS NEEDLES | SUTURE NEEDLE SHUTTLE STERILE | HWQ | SMITH & NEPHEW MANSFIELD MANUFACTURING SITE | 7210693 | 50378589 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |