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 2019-05-08 for SYNFIX? EVOLUTION AWL/WITHOUT SLEEVE 03.835.032 manufactured by Wrights Lane Synthes Usa Products Llc.
[145774510]
Lot number for the entire set is ev24591. The lot number for individual part number is not available. Device is expected to be returned for manufacturer review/investigation, but has not been received yet. Product was not returned. Based on the information available, it has been determined that no corrective and preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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
[145774511]
It was reported that the synfix evolution set, standard instruments-eval was used in surgery on (b)(6) 2019. On (b)(6) 2019, field stocking location (fsl) was informed that the set was ready for pick up on that date. The screw loading station for synfix evolution, synfix evolution awl/without sleeve, handle with quick coupling-small, and two (2) synfix evolution screwdriver without thread lock sleeve was picked up by owens and minors. Upon inspection, qwens and minors found blood on the parts of the set and reported to fsl. It was further clarified that these are instrument trays used by fsal and the trays were discovered to be "soiled". There was no patient involvement. This report is for one (1) synfix evolution awl/without sleeve. This is report 2 of 5 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2019-57894 |
| MDR Report Key | 8591934 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-08 |
| Date of Report | 2019-04-09 |
| Date Mfgr Received | 2019-06-06 |
| Date Added to Maude | 2019-05-08 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHT LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES HAEGENDORF GMBH-CN |
| Manufacturer Street | IM BIFANG 6 |
| Manufacturer City | HAEGENDORF 4614 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 4614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNFIX? EVOLUTION AWL/WITHOUT SLEEVE |
| Generic Name | AWL |
| Product Code | HWJ |
| Date Received | 2019-05-08 |
| Model Number | 03.835.032 |
| Catalog Number | 03.835.032 |
| Lot Number | EV24591 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-05-08 |