Brand Name | ATTUNE RP CR ARTIC SURF SZ7 |
Type of Device | ATTUNE INSTRUMENTS : TIBIAL TRIALS |
Manufacturer (Section D) |
DEPUY IRELAND - 9616671 |
loughbeg ringaskiddy co. |
cork, munster |
EI |
|
Manufacturer (Section G) |
DEPUY ORTHOPAEDICS, INC. 1818910 |
700 orthopaedic dr. |
|
warsaw IN 46582 0988 |
|
Manufacturer Contact |
chad
gibson
|
700 orthopaedic dr. |
warsaw, IN 46582-0988
|
5743725905
|
|
MDR Report Key | 7682699 |
MDR Text Key | 113878555 |
Report Number | 1818910-2018-64319 |
Device Sequence Number | 1 |
Product Code |
JWH
|
UDI-Device Identifier | 10603295133070 |
UDI-Public | 10603295133070 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K140881 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,distri |
Reporter Occupation |
Other Caregivers
|
Type of Report
| Initial,Followup |
Report Date |
06/18/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/12/2018 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 254500567 |
Device Lot Number | MVMBKY440 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/16/2018 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 07/17/2018 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 07/16/2013 |
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 |