FDA Adverse Event
Injury
Summary report: N
CORTICAL SCREW 3.5 X 30MM
MDR report key: 1101765
·
Received August 6, 2008
Report
- Report Number
- 1818910-2008-02935
- Event Type
- Injury
- Date Received
- August 6, 2008
- Date of Event
- July 7, 2008
- Report Date
- July 7, 2008
- Manufacturer
- DEPUY ACE S.A. 'R.L.
- Product Code
- KTW
- PMA / PMN Number
- K905048
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION, ONCE IT HAS BEEN COMPLETED.
Description of Event or Problem · 1
A 3.5MM CORTICAL SCREW BROKE IN HALF DURING DISTAL TIBIA PLATE SURGERY. TIP OF SCREW REMAINED IN PT'S TIBIA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CORTICAL SCREW 3.5 X 30MM | 87KTW | KTW | DEPUY ACE S.A. 'R.L. | NA | DFMB75 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention |