FDA Adverse Event
Other
Summary report: N
OPUS SMARTSTITCH M-CONNECTOR
MDR report key: 2011730
·
Received March 2, 2011
Report
- Report Number
- 2032380-2011-00010
- Event Type
- Other
- Date Received
- March 2, 2011
- Date of Event
- January 7, 2011
- Report Date
- March 2, 2011
- Manufacturer
- ARTHROCARE CORP.
- Product Code
- KOG
- PMA / PMN Number
- K023843
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(6). THE INVESTIGATION IS CURRENTLY IN PROGRESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED TO ARTHROCARE ON (B)(6) 2011 THAT A PATIENT UNDERWENT AN ACHILLES TENDON REATTACHMENT PROCEDURE ON (B)(6) 2011 USING AN OPUS SMARTSTITCH M-CONNECTOR. THE TIP FROM THE RIGHT SIDE NEEDLE BROKE OFF THE SMARTSTITCH M-CONNECTOR WHEN THE MAGNUMWIRE SUTURE CARTRIDGE WAS DEPLOYED. NEEDLE TIP WAS RETRIEVED FROM THE PATIENT BY CUTTING THE ACHILLES TENDON. REPORTEDLY THE SURGERY WAS DELAYED BY 30 MINUTES. PROCEDURE WAS COMPLETED WITH NO ADVERSE REACTIONS TO THE PATIENT AND NO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OPUS SMARTSTITCH M-CONNECTOR | ENDOSCOPE AND ACCESSORIES | KOG | ARTHROCARE CORP. | 1009023 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR | Other |