FDA Adverse Event
Malfunction
Summary report: N
11CM ANGLE ATTACHMENT
MDR report key: 3984305
·
Received December 18, 2013
Report
- Report Number
- 1045834-2013-15699
- Event Type
- Malfunction
- Date Received
- December 18, 2013
- Report Date
- August 2, 2012
- Manufacturer
- DEPUY SYNTHES POWER TOOLS
- Product Code
- HBC
- PMA / PMN Number
- K011444
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- 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 (B)(6) STATING THAT THE DEVICE NEEDED TO BE SERVICED. DURING SERVICING IT WAS FOUND THAT THE DEVICE FAILED THE FOLLOWING ASSESSMENTS: "VISUAL, THIMBLE SET SCREW AND CUTTER INSERTION. IT IS UNK IF THE DEVICE WAS USED DURING SURGERY. IT IS ALSO UNK IF THERE WAS ANY PATIENT OR USER INJURY, MEDICAL INTERVENTION OR SURGICAL DELAY. NO ADDITIONAL INFO AVAILABLE. THE DATE OF THE EVENT IS UNK. IF ADDITIONAL INFO BECOMES AVAILABLE, THIS NOTIFICATION WILL BE UPDATED ACCORDINGLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 663862 | 11CM ANGLE ATTACHMENT | HBC | DEPUY SYNTHES POWER TOOLS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |