Brand Name | ELECTRIC PEN DRIVE 60000RPM |
Type of Device | INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT |
Manufacturer (Section D) |
SYNTHES OBERDORF |
eimattstrasse 3 |
oberdorf CH443 6 |
SZ CH4436 |
|
Manufacturer (Section G) |
SYNTHES OBERDORF |
eimattstrasse 3 |
|
oberdorf CH443 6 |
SZ
CH4436
|
|
Manufacturer Contact |
linda
plews
|
1302 wrights lane east |
west chester, PA 19380
|
6107195000
|
|
MDR Report Key | 5573848 |
MDR Text Key | 43176530 |
Report Number | 8030965-2016-12599 |
Device Sequence Number | 1 |
Product Code |
HWE
|
Combination Product (y/n) | N |
Reporter Country Code | PL |
PMA/PMN Number | PK043310 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Service and Testing Personnel
|
Type of Report
| Initial |
Report Date |
05/12/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/13/2016 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 05.001.010 |
Device Lot Number | N/A |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/12/2015 |
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 05/12/2015 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 04/08/2013 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |