Brand Name | QUICKSET ACE GRATER HEAD 61MM |
Type of Device | HIP INSTRUMENTS : REAMERS |
Manufacturer (Section D) |
DEPUY ORTHOPAEDICS INC US |
700 orthopaedic drive |
warsaw IN 46581 0988 |
|
Manufacturer (Section G) |
DEPUY ORTHOPAEDICS, INC. 1818910 |
700 orthopaedic dr. |
|
warsaw IN 46581 0988 |
|
Manufacturer Contact |
kara
ditty-bovard
|
700 orthopaedic drive |
warsaw, IN 46581-0988
|
6107428552
|
|
MDR Report Key | 9738465 |
MDR Text Key | 190660906 |
Report Number | 1818910-2020-05574 |
Device Sequence Number | 1 |
Product Code |
HTO
|
Combination Product (Y/N) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
COMPANY REPRESENTATIVE,FOREIG |
Type of Report
| Initial,Followup,Followup |
Report Date |
01/27/2020 |
1 Device Was Involved in the Event |
|
0 PatientS WERE Involved in the Event: | |
Date FDA Received | 02/21/2020 |
Is This An Adverse Event Report? |
No
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
HEALTH PROFESSIONAL
|
Device MODEL Number | 2440-00-561 |
Device Catalogue Number | 244000561 |
Device LOT Number | A0608 |
Was Device Available For Evaluation? |
Device Returned To Manufacturer
|
Date Returned to Manufacturer | 09/24/2020 |
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Date Manufacturer Received | 09/24/2020 |
Was Device Evaluated By Manufacturer? |
No
|
Date Device Manufactured | 06/15/2008 |
Is The Device Single Use? |
No
|
Is this a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unkown
|