Brand Name | ASEPTIC TRANSFER KIT HOUSING |
Type of Device | SURGICAL POWER TOOL BATTERY-EXCHANGE STERILITY COVER |
Manufacturer (Section D) |
ZIMMER SURGICAL SA |
3, ch. du pre fleuri |
1228 plan-les-ouates |
geneva CH-12 28 |
SZ CH-1228 |
|
Manufacturer (Section G) |
ZIMMER SURGICAL SA |
3, ch. du pre fleuri |
1228 plan-les-ouates |
geneva CH-12 28 |
SZ
CH-1228
|
|
Manufacturer Contact |
christina
arnt
|
56 e. bell drive |
warsaw, IN 46582
|
5745273773
|
|
MDR Report Key | 16830230 |
MDR Text Key | 314170273 |
Report Number | 0008031000-2023-00014 |
Device Sequence Number | 1 |
Product Code |
MOQ
|
UDI-Device Identifier | 00889024355149 |
UDI-Public | (01)00889024355149(11)180420(10)5010988 |
Combination Product (y/n) | N |
Reporter Country Code | SP |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
04/28/2023 |
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 | N/A |
Device Catalogue Number | 89-8510-440-10 |
Device Lot Number | 5010988 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
11/15/2022
|
Initial Date FDA Received | 04/28/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/20/2018 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Removal/Correction Number | N/A |
Patient Sequence Number | 1 |