Brand Name | ATTUNE DISTAL FEM CUT BLOCK |
Type of Device | ATTUNE INSTRUMENTS : RESECTION BLOCKS/DEVICES |
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 | 12541847 |
MDR Text Key | 273627809 |
Report Number | 1818910-2021-21302 |
Device Sequence Number | 1 |
Product Code |
HTZ
|
UDI-Device Identifier | 10603295423737 |
UDI-Public | 10603295423737 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
08/03/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 09/28/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 2544-00-522 |
Device Catalogue Number | 254400522 |
Device Lot Number | ABB35809 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/16/2021 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 09/27/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/19/2013 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Age | 68 YR |