MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-15 for PERIOSTEAL ELEVATOR 6MM CURVED BLADE-STRAIGHT EDGE 399.40 manufactured by Synthes Usa.
[28696919]
Device is an instrument and is not implanted/explanted. Without a lot number the device history records review could not be completed. The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. 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
[28696920]
It was reported that during a calcaneal fracture repair, a periosteal elevator handle broke in two pieces. The item was placed on the back table and a replacement set was opened and given to the surgeon to complete the procedure. There was no surgical delay in case, no additional medical intervention required and no patient harm. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[31480575]
An investigation summary was performed. The investigation of the complaint articles has shown that: sales consultant reported that during a calcaneal fracture repair, a periosteal elevator (399. 40 lot unknown) handle broke in two pieces. The item was placed on the field (back table) and a replacement (a new set was opened and given to the surgeon to complete the procedure. There was no surgical delay in case, no additional medication intervention required and no patient harm. The complaint condition is confirmed as the returned device was received with the handle broken in two at the cross-pin. While it cannot be definitively determined since the specific circumstances at the time of the break are unknown, the most probable root cause is the method of use and handling over the 13+ year lifespan. This investigation summary is approved. 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
| Report Number | 2520274-2015-16681 |
| MDR Report Key | 5153038 |
| Date Received | 2015-10-15 |
| Date of Report | 2015-10-05 |
| Date of Event | 2015-10-05 |
| Date Mfgr Received | 2015-10-30 |
| Date Added to Maude | 2015-10-15 |
| 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 | LINDA PLEWS |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERIOSTEAL ELEVATOR 6MM CURVED BLADE-STRAIGHT EDGE |
| Generic Name | ELEVATOR |
| Product Code | HTE |
| Date Received | 2015-10-15 |
| Returned To Mfg | 2015-10-12 |
| Catalog Number | 399.40 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES USA |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-15 |