FDA Adverse Event
Malfunction
Summary report: N
M/DN INTRAMEDULLARY FIXATION 4.2MM DIA. CORTICAL SCREW
MDR report key: 1070975
·
Received July 3, 2008
Report
- Report Number
- 2648920-2008-00034
- Event Type
- Malfunction
- Date Received
- July 3, 2008
- Date of Event
- May 2, 2008
- Report Date
- June 5, 2008
- Manufacturer
- ZIMMER MANUFACTURING B.V.
- Product Code
- HSB
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT DURING SURGERY IN 2008, WHEN THE SURGEON WAS INSERTING THE SCREW, THE SCREW BROKE UNDER THE SCREW HEAD. THE SURGEON REMOVED THE BROKEN SCREW AND INSERTED ANOTHER SCREW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | M/DN INTRAMEDULLARY FIXATION 4.2MM DIA. CORTICAL SCREW | CORTICAL SCREW | HSB | ZIMMER MANUFACTURING B.V. | NA | 60393396 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR |