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 DIA DRILL BIT W/6MM STOP 13MM LENGTH F/90? SCREWDRIVER 03.505.041 manufactured by Oberdorf Synthes Produktions Gmbh.
[146111549]
Device evaluated by mfr: the device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. 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
[146111550]
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the tip of the drill bit broke off when the surgeon drilled at the mandible during sagittal ramus osteotomy. The surgeon recognized that the broken tip was difficult to remove and decided to keep the broken tip in the patient's body. There was a surgical delay of less than 30 minutes. The procedure was successfully completed. Patient is in stable condition but still hospitalized.? ? This report is for one (1) 1. 5mm dia drill bit. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2019-64554 |
| MDR Report Key | 8641853 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-24 |
| Date of Report | 2019-04-26 |
| Date of Event | 2019-04-26 |
| Date Mfgr Received | 2019-05-29 |
| Device Manufacturer Date | 2016-01-06 |
| 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 | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| 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 DIA DRILL BIT W/6MM STOP 13MM LENGTH F/90? SCREWDRIVER |
| Generic Name | DRILL, BONE, POWERED |
| Product Code | DZI |
| Date Received | 2019-05-24 |
| Returned To Mfg | 2019-05-20 |
| Catalog Number | 03.505.041 |
| Lot Number | F-17439 |
| 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 | 1. Required No Informationntervention | 2019-05-24 |