Brand Name | ATTUNE REVISION BROACH HANDLE |
Type of Device | HANDLES |
Manufacturer (Section D) |
DEPUY IRELAND - 9616671 |
loughbeg ringaskiddy co. |
cork |
EI |
|
Manufacturer (Section G) |
DEPUY IRELAND 9616671 |
loughbeg, ringaskiddy co. |
|
cork |
EI
|
|
Manufacturer Contact |
kate
karberg
|
700 orthpaedic dr. |
warsaw, IN 46581
|
3035526892
|
|
MDR Report Key | 15000123 |
MDR Text Key | 297003896 |
Report Number | 1818910-2022-12887 |
Device Sequence Number | 1 |
Product Code |
LXH
|
UDI-Device Identifier | 10603295475910 |
UDI-Public | 10603295475910 |
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
07/13/2022 |
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 Model Number | 2546-00-418 |
Device Catalogue Number | 254600418 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
06/27/2022 |
Initial Date FDA Received | 07/13/2022 |
Supplement Dates Manufacturer Received | 07/19/2022
|
Supplement Dates FDA Received | 07/20/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |