Brand Name | TEAR DROP GUIDE WIRE 3.0 MM DIAMETER 70 CM LENGTH |
Type of Device | PROSTHESIS, TRAUMA |
Manufacturer (Section D) |
ZIMMER BIOMET, INC. |
56 e. bell drive |
warsaw IN 46582 |
|
Manufacturer (Section G) |
ZIMMER BIOMET, INC. |
56 e. bell drive |
|
warsaw IN 46582 |
|
Manufacturer Contact |
christina
arnt
|
56 e. bell dr. |
warsaw, IN 46582
|
5745273773
|
|
MDR Report Key | 8362215 |
MDR Text Key | 136881149 |
Report Number | 0001822565-2019-00665 |
Device Sequence Number | 1 |
Product Code |
HSB
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K101622 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
02/22/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 02/28/2021 |
Device Model Number | N/A |
Device Catalogue Number | 47249009800 |
Device Lot Number | 63952775 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/30/2018 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
04/19/2018 |
Initial Date FDA Received | 02/22/2019 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/21/2018 |
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 |
|
|