FDA Adverse Event
Malfunction
Summary report: N
ELITE PASS SHUTTLE NEEDLE
MDR report key: 1010117
·
Received March 10, 2008
Report
- Report Number
- 1219602-2008-00052
- Event Type
- Malfunction
- Date Received
- March 10, 2008
- Date of Event
- February 5, 2008
- Report Date
- February 6, 2008
- Manufacturer
- SMITH & NEPHEW INC., ENDOSCOPY DIV.
- Product Code
- HXI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT IS BEING RETURNED FOR EVAL.
Description of Event or Problem · 1
DURING ROTATOR CUFF DECOMPRESSION, THE TIP OF THE NEEDLE BROKE AND REMAINS EMBEDDED IN THE PT'S TISSUE AS THE SURGEON WAS UNABLE TO RETRIEVE. THE SURGEON USED ANOTHER SHUTTLE NEEDLE TO COMPLETE THE CASE WITHOUT ANY COMPLICATIONS. THE SURGEON DID NOT PRE-DRILL HOWEVER HE USED THE INCISOR BLADE TO DETERMINE PT'S BONE QUALITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ELITE PASS SHUTTLE NEEDLE | JACK NEEDLE | HXI | SMITH & NEPHEW INC., ENDOSCOPY DIV. | 7210693 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |