Brand Name | PIN COLLET (2.0-3.2MM) |
Type of Device | INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT |
Manufacturer (Section D) |
STRYKER INSTRUMENTS-KALAMAZOO |
4100 east milham avenue |
kalamazoo MI 49001 |
|
MDR Report Key | 11002418 |
MDR Text Key | 221242374 |
Report Number | 0001811755-2020-03421 |
Device Sequence Number | 1 |
Product Code |
HWE
|
UDI-Device Identifier | 04546540068163 |
UDI-Public | 04546540068163 |
Combination Product (y/n) | N |
PMA/PMN Number | K943323 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Type of Report
| Initial,Followup |
Report Date |
04/14/2021 |
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 | 4100125000 |
Device Catalogue Number | 4100125000 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/24/2021 |
Initial Date Manufacturer Received |
11/22/2020 |
Initial Date FDA Received | 12/14/2020 |
Supplement Dates Manufacturer Received | 04/13/2021
|
Supplement Dates FDA Received | 04/14/2021
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|