MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2018-04-20 for FRONT LOADING CARTRIDGE KIT VACUUM MIXING SYSTEM N/A 00506905200 manufactured by Zimmer Surgical, Inc..
[106417274]
This event is recorded with zimmer biomet under (b)(4). Once the investigation is complete and/or if additional information becomes available, a follow up mdr will be submitted. Follow up on product return is open.
Patient Sequence No: 1, Text Type: N, H10
[106417275]
It was reported that during cement laying, the plastic nozzle broke. This event occurred during surgery and the breakage was during use. No adverse events have been reported as a result of this malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001526350-2018-00332 |
| MDR Report Key | 7448554 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2018-04-20 |
| Date of Report | 2018-05-09 |
| Date of Event | 2018-03-14 |
| Date Mfgr Received | 2018-05-09 |
| Device Manufacturer Date | 2017-03-28 |
| Date Added to Maude | 2018-04-20 |
| 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 VACUUM MIXING SYSTEM |
| Generic Name | EVACUATOR, VAPOR, CEMENT MONOMER |
| Product Code | JDY |
| Date Received | 2018-04-20 |
| Model Number | N/A |
| Catalog Number | 00506905200 |
| Lot Number | 63589336 |
| ID Number | (01)00889024376870 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-04-20 |