FDA Adverse Event
Malfunction
Summary report: N
CANNULATED SCREW 2.7
MDR report key: 2630925
·
Received June 25, 2012
Report
- Report Number
- 8043862-2012-00005
- Event Type
- Malfunction
- Date Received
- June 25, 2012
- Report Date
- June 21, 2012
- Manufacturer
- AAP IMPLANTATE AG
- Product Code
- HWC
- PMA / PMN Number
- K080101
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
AAP ASSUMES A USER FAULT WHICH OCCURRED BECAUSE OF THE APPLICATION OF THE SCREW WITHOUT PRE-DRILLING INTO THE HARD CORTICAL BONE AS RECOMMENDED IN THE SURGERY TECHNIQUE. THE REASON FOR THIS CONCLUSION IS THE BASED ON THE VISUAL INSPECTION OF THE DAMAGED PART. OUR DISTRIBUTOR CONFIRMED THAT NO FRAGMENTS OF THE SCREW WERE LEFT IN THE BODY.
Description of Event or Problem · 1
ALLEGEDLY AS THE DOCTOR STARTED TO SCREW THE PRODUCT IN, THE SCREW BROKE OFF AT THE TIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CANNULATED SCREW 2.7 | SCREW | HWC | AAP IMPLANTATE AG | SCN271632 | W010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |