MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-11-14 for PERIOSTEAL ELEVATOR 3MM CURVED BLADE-STRAIGHT EDGE 399.48 manufactured by Synthes Tuttlingen.
[93003440]
Patient? S weight is unknown. (b)(4). Lot number unknown. Device is an instrument and is not implanted/explanted. Complainant device is not expected to be returned for manufacturer review/investigation. 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
[93003441]
It was reported that during an open reduction internal fixation (orif) of a pilon fracture performed on (b)(6) 2017, two periosteal elevators broke in half during reduction of fracture fragments. The event did no effect the outcome of the case or cause any significant delay. The time of delay in unknown and patient? S outcome is unknown. This report is for one (1) periosteal elevator 3mm curved blade-straight edge this is report 2 of 2 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680938-2017-10141 |
| MDR Report Key | 7030658 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-11-14 |
| Date of Report | 2017-10-21 |
| Date of Event | 2017-10-21 |
| Date Mfgr Received | 2017-10-21 |
| Date Added to Maude | 2017-11-14 |
| 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 TUTTLINGEN |
| Manufacturer Street | UNTER HASSLEN 5 |
| Manufacturer City | TUTTLINGEN 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERIOSTEAL ELEVATOR 3MM CURVED BLADE-STRAIGHT EDGE |
| Generic Name | ELEVATOR |
| Product Code | HTE |
| Date Received | 2017-11-14 |
| Catalog Number | 399.48 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES TUTTLINGEN |
| Manufacturer Address | UNTER HASSLEN 5 TUTTLINGEN 78532 GM 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-14 |