Brand Name | SIG FEM ADPT TORQUE WRENCH |
Type of Device | KNEE INSTRUMENT : TORQUE DEVICES |
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 dr. |
warsaw, IN 46581-0988
|
6107428552
|
|
MDR Report Key | 9578132 |
MDR Text Key | 176692823 |
Report Number | 1818910-2020-01536 |
Device Sequence Number | 1 |
Product Code |
HXC
|
UDI-Device Identifier | 10603295239789 |
UDI-Public | 10603295239789 |
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,Followup |
Report Date |
12/23/2019 |
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 Model Number | 96-1673 |
Device Catalogue Number | 961673 |
Device Lot Number | A0410 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/08/2020 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/23/2019 |
Initial Date FDA Received | 01/10/2020 |
Supplement Dates Manufacturer Received | 01/24/2020
|
Supplement Dates FDA Received | 01/28/2020
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 04/15/2010 |
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 |