FDA Adverse Event
Malfunction
Summary report: N
EXETER RASP HANDLE
MDR report key: 1629315
·
Received February 5, 2010
Report
- Report Number
- 9610669-2009-00067
- Event Type
- Malfunction
- Date Received
- February 5, 2010
- Date of Event
- July 3, 2006
- Report Date
- February 5, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS CAEN, BENOIST GIRARD & CIE S.C.A
- Product Code
- LXH
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AS PART OF A QUALITY SYSTEM IMPROVEMENT PLAN STRYKER CORP CONDUCTED A 2 YEAR RETROSPECTIVE MDR REVIEW TO ENSURE APPROPRIATE MDR REPORTING DECISIONS. EVENTS REPORTED TO STRYKER FROM (B) (6) 2006 TO (B) (6) 2008 WERE THE SCOPE OF THIS RETROSPECTIVE REVIEW. THESE EVENTS ARE PART OF A RETROSPECTIVE SUMMARY REPORT BEING SUBMITTED UNDER EXEMPTION (B) (4). THERE ARE 18 EVENTS ASSOCIATED WITH THIS EVENT TYPE (DEVICE BROKE OR DISASSEMBLED DURING USER) AND PRODUCT CODE (LXH).
Description of Event or Problem · 1
DEVICE BROKE OR DISASSEMBLED DURING USE. THE CUSTOMER REPORTED VIA THE TM THAT THE SPRING BROKE AND POPPED OUT OF THE DEVICE, IT WAS CONFIRMED THAT NOTHING FELL INTO THE WOUND SITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXETER RASP HANDLE | INSTRUMENT | LXH | STRYKER ORTHOPAEDICS CAEN, BENOIST GIRARD & CIE S.C.A | NA | GC923322 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |