Brand Name | MINIMAL ACCESS ATTACHMENT |
Type of Device | DRILLS, BURRS, TREPHINES & ACCESSORIES - ATTACHMENT |
Manufacturer (Section D) |
DEPUY SYNTHES POWER TOOLS |
4500 riverside drive |
palm beach gardens FL 33410 |
|
Manufacturer (Section G) |
DEPUY SYNTHES POWER TOOLS |
4500 riverside drive |
|
palm beach gardens FL 33410 |
|
Manufacturer Contact |
rodney
crain
|
4500 riverside drive |
palm beach gardens, FL 33410
|
5616271080
|
|
MDR Report Key | 6134428 |
MDR Text Key | 61448455 |
Report Number | 1045834-2016-13319 |
Device Sequence Number | 1 |
Product Code |
HBE
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K042783 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
11/14/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/30/2016 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | MA-D20 |
Device Lot Number | N/A |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 11/14/2016 |
Date Manufacturer Received | 11/14/2016 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/10/2012 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |