FDA Adverse Event
Malfunction
Summary report: N
SLIDING DRILL
MDR report key: 2800259
·
Received October 22, 2012
Report
- Report Number
- 2520274-2012-02407
- Event Type
- Malfunction
- Date Received
- October 22, 2012
- Report Date
- September 24, 2012
- Manufacturer
- SYNTHES USA
- Product Code
- DZI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.
Description of Event or Problem · 1
A DEVICE REPORT FROM SYNTHES (B)(6) INDICATED A HOSPITAL IN (B)(6) REPORTED: DURING A PROCEDURE, THE SURGEON WAS USING A DEVICE, SLIDING DRILL FOR STATIC LOCKING AND THE DEVICE WOULD NOT LOCK. THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE BY FREEHAND LOCKING. THE PROBLEM OCCURS ONLY WHEN THE NAILS ARE LONGER THAN 180 MM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SLIDING DRILL | DZI | SYNTHES USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |