MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-04-13 for HENRY SCHEIN 100-8008 * manufactured by Shanghai Dental Instrument Factory.
[16720932]
Instrument tip broke and patient received small cut on the lip from broken tip. The tip was retrieved and the patient did not require medical intervention.
Patient Sequence No: 1, Text Type: D, B5
[16907576]
The instrument tip was broken at the terminal shank. The microhardness and microstructure evaluated at the tip was normal. The broken surface revealed excessive corrosion consistent with stress corrosion cracking. This dental explorer revealed no similarities to instruments that were within the recalled lots (z-0526/z0529-5) that contained above specification hardness values and irregular microstructures. These types of explorers with regular re-use have a life expectancy of 2 years. The date code printed on the instrument indicated that this instrument was almost 4 years old at the time of breakage. The probable cause of breakage is related to the corrosion that occurred over a period of time and the use of the instrument in that it had exceeded its useful life. The dental office had been notified on three occasions about the ongoing recall (z-0526/0529-5), twice by mail and once by phone. The office had purchased a total of 23 instruments suspected to be within the suspect date range. A total of 20 instruments were returned by this dental office during the course of the recall.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416605-2007-00001 |
| MDR Report Key | 957376 |
| Report Source | 05 |
| Date Received | 2007-04-13 |
| Date of Report | 2007-04-12 |
| Date of Event | 2007-03-15 |
| Date Facility Aware | 2007-03-27 |
| Report Date | 2007-04-12 |
| Date Reported to FDA | 2007-04-13 |
| Date Reported to Mfgr | 2007-04-11 |
| Device Manufacturer Date | 2003-05-01 |
| Date Added to Maude | 2007-12-05 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 3232 NORTH ROCKWELL ST. |
| Manufacturer City | CHICAGO IL 60618 |
| Manufacturer Country | US |
| Manufacturer Postal | 60618 |
| Manufacturer Phone | 7739753975 |
| Manufacturer G1 | IMPORTER OF RECORD AND SPECIFICATION SETTER |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-0526/0529-5 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HENRY SCHEIN |
| Generic Name | DENTAL INSTRUMENT-EXPLORER |
| Product Code | EKB |
| Date Received | 2007-04-13 |
| Returned To Mfg | 2007-03-30 |
| Model Number | 100-8008 |
| Catalog Number | * |
| Lot Number | 0503 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 927815 |
| Manufacturer | SHANGHAI DENTAL INSTRUMENT FACTORY |
| Manufacturer Address | * SHANGHAI CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-04-13 |