FDA Adverse Event
Malfunction
Summary report: N
TORNIER
MDR report key: 1618959
·
Received February 18, 2010
Report
- Report Number
- 9610667-2010-00002
- Event Type
- Malfunction
- Date Received
- February 18, 2010
- Date of Event
- December 10, 2009
- Report Date
- February 18, 2010
- Manufacturer
- TORNIER INC.
- Product Code
- HXX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE INSTRUMENT IS A CLASS I INSTRUMENT. NO 510K IS APPLICABLE. NO FURTHER INFORMATION IS ANTICIPATED FOR THIS EVENT.
Description of Event or Problem · 1
IT IS REPORTED THAT A CLASS I REUSABLE SURGICAL INSTRUMENT BROKE WHILE IN USE. THE INSTRUMENT IS A 3.5MM HEX TIP SCREW DRIVER, CAT MXB991, LOT IS NOT REPORTED. THE INSTRUMENT IS SUPPLIED AS A NON-STERILE AND REUSABLE TOOL. THE INSTRUMENT TIP REMAINS WITHIN THE ORTHOPEDIC IMPLANT, COULD NOT BE EXTRACTED BY THE SURGEON. THE INSTRUMENT RECOVERY AND RETURN FOR ENGINEERING ANALYSIS MAY/MAY NOT OCCUR. NO DEVICE RETURN HAS BEEN ACCOMPLISHED AS OF THIS REPORT DATE. THIS REPORT IS FILED TO RECORD THE EVENT OF AN UNANTICIPATED FOREIGN BODY REMAINING WITHIN THE SURGICAL SITE. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TORNIER | 3.5MM HEX TIP SCREWDRIVER INSTRUMENT | HXX | TORNIER INC. | NOT REPORTED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |