Brand Name | ATTUNE DISTAL FEMORAL JIG |
Type of Device | ATTUNE INSTRUMENTS : ALIGNMENT DEVICES |
Manufacturer (Section D) |
DEPUY IRELAND - 9616671 |
loughbeg ringaskiddy co. |
cork |
EI |
|
Manufacturer (Section G) |
DEPUY ORTHOPAEDICS 1818910 |
700 orthopaedic dr |
|
warsaw IN 46581 0988 |
|
Manufacturer Contact |
kara
ditty-bovard
|
700 orthopaedic dr. |
warsaw, IN 46581-0988
|
6107428552
|
|
MDR Report Key | 12067004 |
MDR Text Key | 258396444 |
Report Number | 1818910-2021-13578 |
Device Sequence Number | 1 |
Product Code |
HWT
|
UDI-Device Identifier | 10603295434030 |
UDI-Public | 10603295434030 |
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,other |
Type of Report
| Initial |
Report Date |
04/26/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/25/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 2544-00-520 |
Device Catalogue Number | 254400520 |
Device Lot Number | ABC98472 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/01/2021 |
Date Manufacturer Received | 06/25/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/23/2014 |
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 |