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 2018-07-23 for COUNTERSINK W/CENTERING PINS F/1.5MM, 2.0MM & 2.7MM SCREWS 310.810 manufactured by Oberdorf Synthes Produktions Gmbh.
[114730397]
This patient information is unknown. Device is an instrument and is not implanted/explanted. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. (510k): device is not distributed in the united states, but is similar to device marketed in the usa. Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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
[114730398]
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that during jaw osteosynthesis surgery with unilock system on (b)(6) 2018, during the perforation with 1. 5 x 12mm drill, the center-pin broke and remained in the patient. The surgery was successfully completed without further issue. It is unknown if there was a surgical delay. Patient outcome is unknown. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2018-55213 |
| MDR Report Key | 7710963 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-07-23 |
| Date of Report | 2018-07-01 |
| Date of Event | 2018-07-01 |
| Date Mfgr Received | 2018-07-01 |
| Date Added to Maude | 2018-07-23 |
| 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 | MR. MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHT LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | WERK BETTLACH (CH) |
| Manufacturer Street | MURACHERSTRASSE 3 |
| Manufacturer City | BETTLACH 2544 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 2544 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COUNTERSINK W/CENTERING PINS F/1.5MM, 2.0MM & 2.7MM SCREWS |
| Generic Name | DRIVER,WIRE,BONE DRILL MANUAL |
| Product Code | DZJ |
| Date Received | 2018-07-23 |
| Catalog Number | 310.810 |
| 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 | 1. Required No Informationntervention | 2018-07-23 |