Brand Name | ATTUNE TIBIAL TRIAL EXTRACTOR |
Type of Device | ATTUNE INSTRUMENTS : EXTRACTION INSTRUMENTS |
Manufacturer (Section D) |
DEPUY IRELAND - 9616671 |
loughbeg ringaskiddy co. |
cork, munster |
EI |
|
Manufacturer (Section G) |
DEPUY ORTHOPAEDICS, INC. 1818910 |
700 orthopaedic dr. |
|
warsaw IN 46581 0988 |
|
Manufacturer Contact |
chad
gibson
|
700 orthopaedic dr. |
warsaw, IN 46581-0988
|
5743725905
|
|
MDR Report Key | 7673715 |
MDR Text Key | 113537291 |
Report Number | 1818910-2018-64118 |
Device Sequence Number | 1 |
Product Code |
HWB
|
UDI-Device Identifier | 10603295131021 |
UDI-Public | 10603295131021 |
Combination Product (y/n) | N |
Reporter Country Code | CA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
06/13/2018 |
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 Catalogue Number | 254500138 |
Device Lot Number | BFA10C7 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/13/2018 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
06/13/2018 |
Initial Date FDA Received | 07/10/2018 |
Date Device Manufactured | 05/14/2015 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |