MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-10-19 for DRILL BIT 1.1 L45/33 2FLUTE 513.030 manufactured by .
[2939703]
A device report from (b)(4) indicated a hospital in (b)(6) reported: during a procedure, the drill bit broke. All fragments were retrieved, nothing was left in the patient. Procedure was completed.
Patient Sequence No: 1, Text Type: D, B5
[10292236]
This device is used for treatment not diagnosis. The measurable dimensions were checked as far as possible and were found to be in compliance with the technical drawings and ao/asif specification. The examination of the manufacturing papers showed no deviations regarding material analysis, strength and structural stability. The values were in compliance with ao/asif specification and with the international standard. The fracture face is homogeneous which indicates material conformity. The cutting edges above the fracture are blunt. We suppose that an excessive metallic contact in combination with too much lateral stress caused this breakage. No product fault could be detected.
Patient Sequence No: 1, Text Type: N, H10
[10302521]
The investigation could not be completed, no conclusion could be drawn, as product is entering the complaint system.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2012-02353 |
| MDR Report Key | 2826673 |
| Report Source | 01,07 |
| Date Received | 2012-10-19 |
| Date of Report | 2012-09-20 |
| Date of Event | 2012-09-20 |
| Date Mfgr Received | 2012-11-21 |
| Date Added to Maude | 2013-01-31 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SHERRY LAING |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRILL BIT 1.1 L45/33 2FLUTE |
| Generic Name | DRILL BIT |
| Product Code | HTT |
| Date Received | 2012-10-19 |
| Returned To Mfg | 2012-09-20 |
| Catalog Number | 513.030 |
| Lot Number | 424267 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-10-19 |