Brand Name | ATTUNE FB TIBIAL IMPACTOR |
Type of Device | ATTUNE INSTRUMENTS : IMPACTORS |
Manufacturer (Section D) |
DEPUY IRELAND - 9616671 |
loughbeg ringaskiddy co. |
cork |
EI |
|
Manufacturer (Section G) |
DEPUY ORTHOPAEDICS, INC. 1818910 |
700 orthopaedic dr. |
|
warsaw IN 46581 0988 |
|
Manufacturer Contact |
kara
ditty-bovard
|
700 orthopaedic dr. |
warsaw, IN 46581-0988
|
6107428552
|
|
MDR Report Key | 12345142 |
MDR Text Key | 267360067 |
Report Number | 1818910-2021-18217 |
Device Sequence Number | 1 |
Product Code |
HWA
|
UDI-Device Identifier | 10603295130192 |
UDI-Public | 10603295130192 |
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Type of Report
| Initial |
Report Date |
04/16/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/19/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 2544-01-003 |
Device Catalogue Number | 254401003 |
Device Lot Number | AU6149338 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/14/2021 |
Date Manufacturer Received | 08/19/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 01/12/2018 |
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 |