Brand Name | BATTERY HANDPIECE/MODULAR FOR TRS |
Type of Device | MOTOR, SURGICAL INSTRUMENT, AC-POWERED |
Manufacturer (Section D) |
DEPUY SYNTHES PRODUCTS LLC |
eimattstrasse 3 |
oberdorf 4436 |
SZ 4436 |
|
Manufacturer (Section G) |
OBERDORF SYNTHES PRODUKTIONS GMBH |
eimattstrasse 3 |
|
oberdorf 4436 |
SZ
4436
|
|
Manufacturer Contact |
michael
cote
|
1302 wrights lane east |
west chester, PA 19380
|
6107195000
|
|
MDR Report Key | 8001274 |
MDR Text Key | 124965591 |
Report Number | 8030965-2018-57552 |
Device Sequence Number | 1 |
Product Code |
GEY
|
UDI-Device Identifier | 7611819977815 |
UDI-Public | (01)7611819977815(11)170314 |
Combination Product (y/n) | N |
Reporter Country Code | FR |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
10/03/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 10/24/2018 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 05.001.201 |
Device Lot Number | N/A |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 10/19/2018 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 10/03/2018 |
Date Device Manufactured | 03/14/2017 |
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 |