MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-09-02 for HENRY SCHEIN EXPLORER DE #5 * 1008008 manufactured by Worldsource Inc, Hufriedy Mfg.
[350322]
Add'l info rec'd from distributor 11/14/03: the instruments were returned with the two complaints for evlauation. The two complaints were from separate doctors. Facility looked at the fracture surfaces of the broken instruments and took some hardness values of the tips. The fracture surfaces did not really reveal much for facility's evaluation. They appeared to be brittle failures, with nothing implicating a problem with the material or structure of the instrument. The tips of the returned instruments all seem to be dimensionally intact as well. All of the returned tips fall within facility's specifications range. Facility attempted to duplicate the incident of the tip breaking by pressing on a few that were sent back unnbroken with the complaints. In one instance, it took excessive force to finally break the tip off, and in another case, the tip did not break off, it just continued to bend back when pressure was applied. The total number of parts returned was fifteen, then adding the one from this incident makes sixteen. The sixteen instruments returned were from only three doctors, twelve instruments from one doctor, three from another, and the one involved here. There does not seem to be a problem with the instruments themselves or how the instruments are made. There are isolated incidents, the reason for the tips breaking is a probable user error in the amount of force that they are applying when using this instrument.
Patient Sequence No: 1, Text Type: D, B5
[18606424]
During routine exam by dentist, the head of the explorer snapped completely off and was swallowed by the pt. Sent to e. R. For evaluation-confirmed via x-ray that tip was present. 6 days later x-ray confirmed that the tip had passed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2411236-2003-10121 |
| MDR Report Key | 480814 |
| Date Received | 2003-09-02 |
| Date of Report | 2003-09-02 |
| Date of Event | 2003-08-21 |
| Date Facility Aware | 2003-08-21 |
| Report Date | 2003-09-02 |
| Date Reported to FDA | 2003-09-02 |
| Date Reported to Mfgr | 2003-09-02 |
| Date Added to Maude | 2003-09-03 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HENRY SCHEIN EXPLORER DE #5 |
| Generic Name | * |
| Product Code | EKB |
| Date Received | 2003-09-02 |
| Model Number | * |
| Catalog Number | 1008008 |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 469670 |
| Manufacturer | WORLDSOURCE INC, HUFRIEDY MFG |
| Manufacturer Address | 3232 N ROCKWELL ST CHICAGO IL 60618 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-09-02 |