MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-05 for PERIOSTEAL ELEVATOR 3MM CURVED BLADE-STRAIGHT EDGE 399.48 manufactured by Wrights Lane: Synthes Usa Products Llc.
[97724328]
No patient involvement. It is unknown when the event occurred. 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. 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
[97724329]
It was reported that several instruments at the facility are discolored. The cannulated 4. 0mm hexagonal screwdriver, the periosteal elevator 3mm curved blade (straight edge), the periosteal elevator 3mm curved blade (round edge), and the holding sleeve. When peel packed, the handles are leaching a brown substance on the the backing of the peel pack. The handles have a dull, rough finish. There was no patient involvement. This complaint involves four (4) devices. This report is for a curved blade (straight edge) elevator. This report is 2 of 4 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2018-50098 |
| MDR Report Key | 7167581 |
| Date Received | 2018-01-05 |
| Date of Report | 2017-12-06 |
| Date of Event | 2017-12-06 |
| Date Mfgr Received | 2018-02-01 |
| Date Added to Maude | 2018-01-05 |
| 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 | 0 |
| Brand Name | PERIOSTEAL ELEVATOR 3MM CURVED BLADE-STRAIGHT EDGE |
| Generic Name | ELEVATOR |
| Product Code | HTE |
| Date Received | 2018-01-05 |
| Returned To Mfg | 2018-01-09 |
| Catalog Number | 399.48 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHTS LANE: SYNTHES USA PRODUCTS LLC |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-05 |