MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-04-10 for BIOMET LOANER TRAY INSTRUMENTATION TAPERLOC RPP PAN - * manufactured by Biomet, Inc.
[16915015]
Loaner surgical tray instruments for scheduled procedures are to be delivered thoroughly cleaned, inspected and tested for proper function. Contaminated instruments were discovered after putting through washers for a final wash. A significant amount of bioburden was discovered in two trial broaches (6. 0 and 9. 0) in pan 4 of 6 taperloc rpp.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3766156 |
| MDR Report Key | 3766156 |
| Date Received | 2014-04-10 |
| Date of Report | 2014-04-10 |
| Date of Event | 2014-04-01 |
| Report Date | 2014-04-10 |
| Date Reported to FDA | 2014-04-10 |
| Date Reported to Mfgr | 2014-04-23 |
| Date Added to Maude | 2014-04-23 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOMET LOANER TRAY INSTRUMENTATION TAPERLOC RPP PAN - |
| Generic Name | BROACH |
| Product Code | EKW |
| Date Received | 2014-04-10 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET, INC |
| Manufacturer Address | P. O. BOX 587 WARSAW * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-10 |