Brand Name | UNKNOWN ALPS 2.7 DRILL |
Type of Device | TRAUMA, INSTRUMENT |
Manufacturer (Section D) |
ZIMMER BIOMET, INC. |
56 e. bell drive |
p.o. box 587 |
warsaw IN 46581 |
|
Manufacturer (Section G) |
ZIMMER BIOMET, INC. |
56 e. bell drive |
p.o. box 587 |
warsaw IN 46581 |
|
Manufacturer Contact |
jennifer
rapsavage
|
56 e. bell dr. |
warsaw, IN 46582
|
5745260384
|
|
MDR Report Key | 15761751 |
MDR Text Key | 305917526 |
Report Number | 0001825034-2022-02555 |
Device Sequence Number | 1 |
Product Code |
LXH
|
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | N/A |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial,Followup |
Report Date |
01/04/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/09/2022 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | N/A |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 12/07/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|