Brand Name | QUICKSET 1PC FLEX DRILL BIT 25 |
Type of Device | DRILLS (BITS, SLEEVES, GUIDES) : DRILLS |
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
|
1210 ward avenue |
west chester, PA 19380
|
6107428552
|
|
MDR Report Key | 8627609 |
MDR Text Key | 145634528 |
Report Number | 1818910-2019-94144 |
Device Sequence Number | 1 |
Product Code |
HTW
|
UDI-Device Identifier | 10603295109129 |
UDI-Public | 10603295109129 |
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 |
05/06/2019 |
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 Catalogue Number | 227425500 |
Device Lot Number | PG278057 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/28/2019 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
05/06/2019
|
Initial Date FDA Received | 05/21/2019 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/28/2018 |
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 |