MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-05-24 for ?1.5MM DRILL BIT W/6MM STOP 13MM F/90? SCRWDRVR MTRXMANDBL 03.505.075 manufactured by Oberdorf Synthes Produktions Gmbh.
[146071126]
Additional procode: dzj. The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[146071127]
It was reported that on (b)(6) 2019, during sagittal split ramus osteotomy, a matrixmandible drill bit that was connected to an unknown handpiece was broken when the surgeon performed drilling using a handle for 90 degrees screwdriver. There were no fragments left in the patient's body. There was approximately a 15-minutes surgical delay. Surgical procedure was successfully completed. There was no adverse consequence to the patient. Concomitant device reported: handle for screwdriver (part# 03. 505. 004, lot# unknown, quantity 1); this complaint involves one (1) broca drill bit. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2019-64521 |
| MDR Report Key | 8640422 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-24 |
| Date of Report | 2019-04-25 |
| Date of Event | 2019-04-25 |
| Date Mfgr Received | 2019-07-02 |
| Device Manufacturer Date | 2018-02-15 |
| Date Added to Maude | 2019-05-24 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | EIMATTSTRASSE 3 |
| Manufacturer City | OBERDORF 4436 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 4436 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | SYNTHES SELZACH |
| Manufacturer Street | BOHACKERWEG 5 |
| Manufacturer City | SELZACH 2545 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 2545 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ?1.5MM DRILL BIT W/6MM STOP 13MM F/90? SCRWDRVR MTRXMANDBL |
| Generic Name | DRILL, BONE, POWERED |
| Product Code | DZI |
| Date Received | 2019-05-24 |
| Returned To Mfg | 2019-05-20 |
| Catalog Number | 03.505.075 |
| Lot Number | F-23850 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OBERDORF SYNTHES PRODUKTIONS GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF 4436 SZ 4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-24 |