FDA Adverse Event
Malfunction
Summary report: N
OMNISPAN W/12 DEGREE NEEDLE
MDR report key: 1854459
·
Received September 3, 2010
Report
- Report Number
- 1221934-2010-00306
- Event Type
- Malfunction
- Date Received
- September 3, 2010
- Date of Event
- August 30, 2010
- Report Date
- August 30, 2010
- Manufacturer
- DEPUY MITEK
- Product Code
- MBI
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MITEK IS AT THIS POINT IN TIME IN THE INFORMATION GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND THOROUGHLY INVESTIGATED AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT MATTER IN A FOLLOW-UP REPORT.
Description of Event or Problem · 1
THE SALES REP REPORTED THE SILICONE TUBING FROM AN OMNISPAN DEVICE FELL INTO THE PATIENT DURING A MENISCAL REPAIR PROCEDURE. THE BACKSTOP PULLED THE TUBING OUT AS IT WAS BEING DEPLOYED. THE SURGEON EASILY REMOVED THE ENTIRE PIECE OF TUBING FROM THE PATIENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO HARM OR CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OMNISPAN W/12 DEGREE NEEDLE | MENISCAL FASTENER | MBI | DEPUY MITEK | 228141 | 3434512 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |