Brand Name | STERILIZABLE BATTERY |
Type of Device | SURGICAL POWER TOOL |
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 | 18424675 |
MDR Text Key | 331810311 |
Report Number | 0008031000-2024-00003 |
Device Sequence Number | 1 |
Product Code |
MOQ
|
UDI-Device Identifier | 00889024581722 |
UDI-Public | (01)00889024581722(11)210818(10)202107 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
01/02/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/02/2024 |
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 | 89-8521-470-20 |
Device Lot Number | 202107 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/09/2023 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 12/28/2023 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 08/18/2021 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Removal/Correction Number | N/A |
Patient Sequence Number | 1 |
Patient Sex | Prefer Not To Disclose |