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 2017-10-26 for PERIOSTEAL ELEVATOR 6MM CURVED BLADE-ROUND EDGE 399.360 manufactured by Synthes Salzburg.
[90940792]
No patient involvement was reported. Device is an instrument and is not implanted/explanted. Complainant part is not expected to be returned for manufacturer review/investigation. Hospital telephone not available for reporting. The investigation could not be completed; no conclusion could be drawn, as no product was received. Dhr review was completed. Manufacturing location: (b)(4). Manufacturing date: 31. Mar. 2008. No ncrs were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. 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
[90940793]
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that the periosteal elevator broke. It is not known how the issue occurred. No patient or surgical involvement. This report is for one (1) periosteal elevator 6mm curved blade-round edge this is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009417901-2017-10022 |
| MDR Report Key | 6982173 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-10-26 |
| Date of Report | 2017-10-05 |
| Date of Event | 2017-10-02 |
| Date Mfgr Received | 2017-10-05 |
| Device Manufacturer Date | 2008-03-31 |
| Date Added to Maude | 2017-10-26 |
| 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 | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES SALZBURG |
| Manufacturer Street | KAROLINGERSTRASSE |
| Manufacturer City | SALZBURG 5020 |
| Manufacturer Country | AU |
| Manufacturer Postal Code | 5020 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERIOSTEAL ELEVATOR 6MM CURVED BLADE-ROUND EDGE |
| Generic Name | ELEVATOR |
| Product Code | HTE |
| Date Received | 2017-10-26 |
| Catalog Number | 399.360 |
| Lot Number | 5017895 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES SALZBURG |
| Manufacturer Address | KAROLINGERSTRASSE SALZBURG 5020 AU 5020 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-26 |