MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-29 for ENTRY PORTAL N/A 211201104 manufactured by Zimmer Biomet, Inc..
[88169867]
Complaint was confirmed through review of received product. Visual inspection identified intermittent reddish-brown spots (likely rust) throughout the length of the cannula, the spots in cannula are small. No exterior signs of contamination or rust even in laser etch indicating that product was likely properly passivated in manufacturing. Investigation results concluded that the reported event was due to oxidation most likely during cleaning/sterilization, it is a known risk with reusable instruments. There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation. In care and handling of surgical instruments under cleaning and decontamination, number 3 states: "excessively acidic or alkaline solutions may corrode aluminum instruments or instrument cases. "
Patient Sequence No: 1, Text Type: N, H10
[88169868]
It was reported that the item was marked in cannulation area and has been handed to representative as part of delivery of items for return. Customer suspects corrosion and returned for investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2017-07621 |
| MDR Report Key | 6905383 |
| Date Received | 2017-09-29 |
| Date of Report | 2017-09-29 |
| Date of Event | 2014-06-12 |
| Date Mfgr Received | 2014-06-12 |
| Device Manufacturer Date | 2012-08-02 |
| Date Added to Maude | 2017-09-29 |
| 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 DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER BIOMET, INC. |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ENTRY PORTAL |
| Generic Name | AFFIXUS HIP FRACTURE NAIL |
| Product Code | JDO |
| Date Received | 2017-09-29 |
| Returned To Mfg | 2014-08-12 |
| Model Number | N/A |
| Catalog Number | 211201104 |
| Lot Number | SO2004697 |
| ID Number | N/A |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER BIOMET, INC. |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-29 |