MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-12 for PERSONA PSN TRAY manufactured by Zimmer Biomet.
[123952524]
Zimmer instrument tray - persona psn tray series has metal holders for placement of instruments in correct location in the tray. The holders/plates are attached to the metal tray. There are gaps between the holder and the tray. Small pieces of bone/cement/foreign object can get caught between the holder and the tray. This is not visible during the decontamination process and may not get removed during soaking, spraying, and washing process. Has been found prior to being used, during the inspection process in the operating room, between the pan and the papers that pad the tray. This has been reported to the zimmer site rep as a concern.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080554 |
| MDR Report Key | 7965071 |
| Date Received | 2018-10-12 |
| Date of Report | 2018-10-11 |
| Date of Event | 2018-09-27 |
| Date Added to Maude | 2018-10-15 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PERSONA PSN TRAY |
| Generic Name | TRAY, SURGICAL |
| Product Code | LRP |
| Date Received | 2018-10-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER BIOMET |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-10-12 |