Brand Name | CORDLESS DRIVER 3 HANDPIECE |
Type of Device | ARTHROSCOPE |
Manufacturer (Section D) |
STRYKER INSTRUMENTS-KALAMAZOO |
4100 east milham avenue |
kalamazoo MI 49001 |
|
Manufacturer (Section G) |
STRYKER INSTRUMENTS-KALAMAZOO |
4100 east milham avenue |
|
kalamazoo MI 49001 |
|
Manufacturer Contact |
zach
baker
|
4100 east milham avenue |
kalamazoo, MI 49001
|
2693237700
|
|
MDR Report Key | 8122301 |
MDR Text Key | 129031223 |
Report Number | 0001811755-2018-02623 |
Device Sequence Number | 1 |
Product Code |
HRX
|
UDI-Device Identifier | 07613154641284 |
UDI-Public | 07613154641284 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K943323 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
11/30/2018 |
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 |
Other
|
Device Catalogue Number | 4300000000 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 11/15/2018 |
Initial Date Manufacturer Received |
11/17/2018 |
Initial Date FDA Received | 12/01/2018 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 08/17/2009 |
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 |