FDA Adverse Event
Other
Summary report: N
CAPS-LOCK CANNULA
MDR report key: 1676916
·
Received May 5, 2010
Report
- Report Number
- 2951580-2010-00052
- Event Type
- Other
- Date Received
- May 5, 2010
- Date of Event
- April 13, 2010
- Report Date
- May 5, 2010
- Manufacturer
- ARTHROCARE CORP.
- Product Code
- GEA
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS RETURNING TO ARTHROCARE FOR INVESTIGATION. A F/U REPORT WILL BE PROVIDED ONCE THE LOT HISTORY RECORD REVIEW AND INVESTIGATION ARE COMPLETED.
Description of Event or Problem · 1
ON (B)(6) 2010, THE PT UNDERWENT A CAPSULA SHIFT SHOULDER REPAIR USING A DEVICE USING A CAPS-LOCK CANNULA. ONE CENTIMETER OF THE CAPS-LOCK CANNULA BROKE WHILE IT WAS IN THE PT. THE SURGEON WAS UNABLE TO FIND THE PIECE OF PLASTIC AND IT IS UNK WHETHER THE PIECE OF THE DEVICE REMAINS IN THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAPS-LOCK CANNULA | CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY | GEA | ARTHROCARE CORP. | M212812 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Other |