MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-08-15 for PERIOSTEAL ELEVATOR 3MM CURVED BLADE - ROUND EDGE 399.481 manufactured by Wrights Lane Synthes Usa Products Llc.
[117151573]
There was no known reported patient involvement associated with the complained event. Device is an instrument and is not implanted/explanted. The subject device has been received and the product evaluation is in progress. No conclusion can be drawn. A review of the device history records has been requested and is currently pending completion. 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
[117151574]
It was reported that on (b)(6) 2018, the central processing manager presented one (1) periosteal elevator curved blade-round edge, one (1) periosteal elevator curved blade-straight edge, one (1) cruciform screwdriver, and one (1) reduction forceps with points ratchet that were cracked or broken. It was unknown when the devices became damaged. There was no patient involvement. This report is for one (1) periosteal elevator 3mm curved blade - round edge. This is report 1 of 4 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2018-53332 |
| MDR Report Key | 7784452 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-08-15 |
| Date of Report | 2018-07-31 |
| Date Mfgr Received | 2018-09-21 |
| Device Manufacturer Date | 2004-06-29 |
| Date Added to Maude | 2018-08-15 |
| 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 | MR. MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHT 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 | 2018-08-15 |
| Returned To Mfg | 2018-08-14 |
| Model Number | 399.481 |
| Catalog Number | 399.481 |
| Lot Number | A7NA24 |
| 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 | 2018-08-15 |