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 2019-02-11 for 1.1MM DRILL BIT/MINI QC WITH 4MM STOP/44.5MM 317.240 manufactured by Oberdorf Synthes Produktions Gmbh.
[136872797]
Additional device product codes: erl; hbe. Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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
[136872798]
Device report from synthes reports an event in (b)(6) as follows: it was reported that a patient underwent reduction of facial mass fracture on (b)(6) 2019. A drill bit broke during drilling in the patient's bone prior to insertion of the cortex screw. The cortex screw was introduced into the patient, but when reviewing the depth, the doctor saw the need to change the implant for a longer one to obtain the desired result. The broken piece was recovered as it was not inserted in the patient. Procedure was successfully completed with no surgical delay. The patient has not presented anything, the surgery was performed without problems. This report is for one (1) 1. 1mm drill bit/mini qc with 4mm stop. This is report 1 of 2 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2019-60888 |
| MDR Report Key | 8329104 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-02-11 |
| Date of Report | 2019-01-22 |
| Date of Event | 2019-01-21 |
| Date Mfgr Received | 2019-01-22 |
| Date Added to Maude | 2019-02-11 |
| 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 | MONUMENT |
| Manufacturer Street | 1101 SYNTHES AVENUE |
| Manufacturer City | MONUMENT CO 80132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 1.1MM DRILL BIT/MINI QC WITH 4MM STOP/44.5MM |
| Generic Name | DRILL, BONE, POWERED |
| Product Code | DZI |
| Date Received | 2019-02-11 |
| Catalog Number | 317.240 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-02-11 |