Brand Name | QUICKSET ACE GRATER HEAD 68MM |
Type of Device | HIP INSTRUMENTS : REAMERS |
Manufacturer (Section D) |
DEPUY ORTHOPAEDIC INC, 1818910 |
700 orthopaedic drive |
warsaw IN 46582 |
|
Manufacturer (Section G) |
DEPUY ORTHOPAEDIC INC, 1818910 |
700 orthopaedic drive |
|
warsaw IN 46582 |
|
Manufacturer Contact |
chad
gibson
|
700 orthopaedic drive |
warsaw, IN 46582
|
5743725905
|
|
MDR Report Key | 7258738 |
MDR Text Key | 99635568 |
Report Number | 1818910-2018-53089 |
Device Sequence Number | 1 |
Product Code |
HTO
|
UDI-Device Identifier | 10603295124153 |
UDI-Public | 10603295124153 |
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 |
Health Professional
|
Type of Report
| Initial,Followup,Followup,Followup |
Report Date |
01/24/2018 |
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 | 244000568 |
Device Lot Number | SO2020959 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/16/2018 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/24/2018 |
Initial Date FDA Received | 02/09/2018 |
Supplement Dates Manufacturer Received | 02/22/2018 03/19/2018 06/18/2018
|
Supplement Dates FDA Received | 03/01/2018 03/28/2018 06/21/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 09/21/2015 |
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 |