FDA Adverse Event
Malfunction
Summary report: N
AUTOLUBE-III WITH DETENTS & FR. GUARD
MDR report key: 3984288
·
Received December 18, 2013
Report
- Report Number
- 1045834-2013-16057
- Event Type
- Malfunction
- Date Received
- December 18, 2013
- Date of Event
- September 19, 2012
- Report Date
- September 19, 2012
- Manufacturer
- DEPUY SYNTHES POWER TOOLS
- Product Code
- GEY
- PMA / PMN Number
- K970530
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE INVESTIGATION IS STILL IN PROGRESS. WHEN THE INVESTIGATION HAS BEEN COMPLETED OR ADDITIONAL INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. REF: (B)(4).
Description of Event or Problem · 1
REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE HAD "DEBRIS IN OIL." IT IS KNOWN THAT THE DEVICE WAS BEING USED DURING SURGERY BUT NO PATIENT OR USER INJURY OCCURRED. IT IS KNOWN THAT THERE WAS NO DELAY IN THE SURGICAL PROCEDURE AS A RESULT OF THE DEVICE ISSUE. THERE WAS NO ADDITIONAL INFO PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 664043 | AUTOLUBE-III WITH DETENTS & FR. GUARD | GEY | DEPUY SYNTHES POWER TOOLS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |