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 2017-11-08 for FRONT LOADING CARTRIDGE KIT N/A 00506905200 manufactured by Zimmer Surgical, Inc..
[92533231]
(b)(4). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[92533232]
It was reported that a hair like substance was found in the sterile packaging of a cartridge kit. No adverse events were reported as a result of this malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001526350-2017-00833 |
| MDR Report Key | 7010377 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-11-08 |
| Date of Report | 2017-12-09 |
| Date Mfgr Received | 2017-12-09 |
| Device Manufacturer Date | 2016-10-19 |
| Date Added to Maude | 2017-11-08 |
| 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, INC. |
| Manufacturer Street | 200 WEST OHIO AVENUE |
| Manufacturer City | DOVER OH 44622 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44622 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FRONT LOADING CARTRIDGE KIT |
| Generic Name | EVACUATOR, VAPOR, CEMENT MONOMER |
| Product Code | JDY |
| Date Received | 2017-11-08 |
| Returned To Mfg | 2017-12-04 |
| Model Number | N/A |
| Catalog Number | 00506905200 |
| Lot Number | 63476115 |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER SURGICAL, INC. |
| Manufacturer Address | 200 WEST OHIO AVENUE DOVER OH 44622 US 44622 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-08 |