MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-12-30 for ASEPTIC TRANSFER KIT HOUSING N/A 89-8510-440-10 manufactured by Zimmer Surgical Sa.
[177850674]
(b)(4). After several attempts, the device will not be returned to the manufacturer. Therefore, it could not be inspected in an effort to confirm the defect. Device history record review could not performed as the lot number remains unknown. A follow-up medwatch will be submitted if the product is returned or if additional information is received.
Patient Sequence No: 1, Text Type: N, H10
[177850675]
It was reported that the aseptic transfer kit housing (atk) part number 89-8510-440-10 was not working as intended and it opened during surgery. Despite attempts, it was not possible to know the lot number of the product or if the event occured in the sterile area. No extension of surgery was reported. There was no harm or injury to patient/operator reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008031000-2019-00022 |
| MDR Report Key | 9528981 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-12-30 |
| Date of Report | 2019-12-30 |
| Date of Event | 2019-04-30 |
| Date Mfgr Received | 2019-12-19 |
| Date Added to Maude | 2019-12-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER SURGICAL SA |
| Manufacturer Street | 3, CH. DU PRE FLEURI 1228 PLAN-LES-OUATES |
| Manufacturer City | GENEVA CH-1228 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH-1228 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASEPTIC TRANSFER KIT HOUSING |
| Generic Name | ASEPTIC TRANSFER KIT HOUSING |
| Product Code | MOQ |
| Date Received | 2019-12-30 |
| Model Number | N/A |
| Catalog Number | 89-8510-440-10 |
| Lot Number | NOT COMMUNICATED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER SURGICAL SA |
| Manufacturer Address | 3, CH. DU PRE FLEURI 1228 PLAN-LES-OUATES GENEVA CH-1228 SZ CH-1228 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-12-30 |