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 2018-01-05 for PERIOSTEAL ELEVATOR 3MM CURVED BLADE - ROUND EDGE 399.481 manufactured by Wrights Lane: Synthes Usa Products Llc.
[97484420]
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. Part number: 399. 481, lot number: t926225. Date of manufacture: 02jun2008. (b)(4). Description of dhr review: a review of the device history record from the manufacturing site (b)(4) showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint. 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
[97484421]
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 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 (round edge) elevator. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2018-50099 |
| MDR Report Key | 7167677 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-01-05 |
| Date of Report | 2017-12-06 |
| Date Mfgr Received | 2018-02-01 |
| Device Manufacturer Date | 2008-06-02 |
| 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 | 3 |
| Brand Name | PERIOSTEAL ELEVATOR 3MM CURVED BLADE - ROUND EDGE |
| Generic Name | ELEVATOR |
| Product Code | HTE |
| Date Received | 2018-01-05 |
| Returned To Mfg | 2018-01-15 |
| Model Number | 399.481 |
| Catalog Number | 399.481 |
| Lot Number | T926225 |
| 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 |