FDA Adverse Event
Malfunction
Summary report: N
ELITE PASS SHUTTLE NEEDLE
MDR report key: 1014075
·
Received March 14, 2008
Report
- Report Number
- 1219602-2008-00064
- Event Type
- Malfunction
- Date Received
- March 14, 2008
- Date of Event
- February 1, 2008
- Report Date
- February 13, 2008
- Manufacturer
- SMITH & NEPHEW INC., ENDOSCOPY DIV.
- Product Code
- FMI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE IS AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED BY THE MFR.
Description of Event or Problem · 1
DURING A ROTATOR CUFF REPAIR THE NEEDLE BROKE AS IT WAS BEING PASSED THROUGH THE CUFF. AS THE NEEDLE CAME THROUGH, IT WAS NOTICED THAT THE TIP WAS MISSING. THEY BROUGHT IN A C-ARM TO LOCATE THE BROKEN TIP, BUT WAS UNSUCCESSFUL. SALES REP INDICATED THE CUFF THICKNESS WAS AVERAGE. THERE WERE FOUR PASSES WITH THIS NEEDLE. THE NEEDLE WAS NOT REUSED; THE SURGEON USED ANOTHER ELITE PASS TO COMPLETE THE PROCEDURE. SALES REP INDICATED, HE WILL SEND IN THE DEVICE (MINUS THE TIP) FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ELITE PASS SHUTTLE NEEDLE | JACK NEEDLE | FMI | SMITH & NEPHEW INC., ENDOSCOPY DIV. | 7210693 | 50237944 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |