MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-11-17 for PERIOSTEAL ELEVATOR 6MM CURVED BLADE-ROUND EDGE 399.36 manufactured by Synthes Usa.
[31389566]
(b)(4). Device is an instrument and is not implanted/explanted. Device has been discarded and will not be returned. Service history review: part no. 399. 36, lot no: xxxxxna: no service history review can be performed because the lot number cannot be traced. The manufacture date is unknown. The service history evaluation is unconfirmed. 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
[31389567]
It was reported that the elevator was being used during a case and the fake wooden handle broke apart into tiny pieces. Another device was readily available; the delay in surgery was no more than forty-five (45) seconds. No pieces of the broken device went into the patient. There was no harm to the patient. The item will not be returned because the nurse had thrown the item away in the sharps container. This is report 1 of 1 for com-(b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2520274-2015-17337 |
| MDR Report Key | 5229911 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-11-17 |
| Date of Report | 2015-10-30 |
| Date Mfgr Received | 2015-10-30 |
| Date Added to Maude | 2015-11-17 |
| 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-ROUND EDGE |
| Generic Name | ELEVATOR |
| Product Code | HTE |
| Date Received | 2015-11-17 |
| Catalog Number | 399.36 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2015-11-17 |