Brand Name | BONE SCREW DRILL 3.2 MM DIAMETER |
Type of Device | INSTRUMENT, SURGICAL |
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 | 9653531 |
MDR Text Key | 177373618 |
Report Number | 0001822565-2020-00416 |
Device Sequence Number | 1 |
Product Code |
HTW
|
Combination Product (Y/N) | N |
Reporter Country Code | JA |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
DISTRIBUTOR,FOREIGN,HEALTH PR |
Reporter Occupation |
|
Type of Report
| Initial,Followup,Followup |
Report Date |
03/19/2020 |
1 Device Was Involved in the Event |
|
1 Patient Was Involved in the Event | |
Date FDA Received | 01/31/2020 |
Is This An Adverse Event Report? |
Yes
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
HEALTH PROFESSIONAL
|
Device MODEL Number | N/A |
Device Catalogue Number | 00512008500 |
Device LOT Number | 55427000 |
Was Device Available For Evaluation? |
Device Returned To Manufacturer
|
Date Returned to Manufacturer | 02/03/2020 |
Is The Reporter A Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Event Location |
No Information
|
Date Manufacturer Received | 03/18/2020 |
Was Device Evaluated By Manufacturer? |
Yes
|
Date Device Manufactured | 11/05/2002 |
Is The Device Single Use? |
No
|
Is this a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unkown
|
Patient TREATMENT DATA |
Date Received: 01/31/2020 Patient Sequence Number: 1 |
|
|