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 2018-11-06 for SYNFIX? EVOLUTION AWL/WITHOUT SLEEVE 03.835.032 manufactured by Wrights Lane Synthes Usa Products Llc.
[126345330]
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Complainant part is not expected to be returned for manufacturer review/investigation.. (b)(4). A review of the device history records has been requested. The investigation could not be completed; no conclusion could be drawn. Based on the information available, it has been determined that no corrective and/or 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.
Patient Sequence No: 1, Text Type: N, H10
[126345331]
It was reported that on (b)(6) 2018, anterior lumbar interbody fusion (alif) was performed at l4-s1 with synthes synfix evolution. There were difficulties placing one of the s1 screws on the l5-s1 level. After inserting the spacer at l5-s1, the awl was placed through the aiming device to cannulate s1. It was very difficult to fully advance the awl into the "sclerotic" bone that the patient had at s1. The awl appeared to be 15mm in length but the screws being used were 25mm. This left 10mm of bone not prepped for a screw. This was confirmed by viewing the ct scan on the imaging in the room - the bone was dense and sclerotic. After advancing the awl by malleting and twisting, a fine tip screw was placed into the hole of s1. After advancing the screw about 2/3 of the way through that plate on the spacer, the screw would not advance anymore. The screw was taken out. The surgeon wanted to drill into recannulated hole deeper into s1 so he could allow the screw to advance. With no drill option, the aiming device was elected to be taken off and the awl "freehand" was used which is not suggested in the technique guide. The screw was placed without the aiming device attached to the spacer. Using the standard screwdriver, the surgeon could only get the screw to advance about 2/3 of the way through the plate. Then, the straight screwdriver was used to get more axial pressure to advance the screw. And surgeon had to mallet occasionally to get the screw to advance, which ended up getting the screw to advance and lock into the plate. There were no issues with the remaining screws advancing using the awl through the aiming device. The procedure was completed successfully. There was a surgical delay of 10 minutes. Patient status is unknown. This complaint is for one (1) synfix? Evolution awl/without sleeve. Concomitant device reported: unknown plate (part # unknown, lot # unknown, quantity 1). This complaint involves three (3) devices. This report is 3 of 3 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2018-54875 |
| MDR Report Key | 8044105 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-11-06 |
| Date of Report | 2018-10-19 |
| Date of Event | 2018-10-19 |
| Date Mfgr Received | 2018-11-19 |
| Date Added to Maude | 2018-11-06 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. 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 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 | 2018-11-06 |
| Model Number | 03.835.032 |
| Catalog Number | 03.835.032 |
| 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 | 1. Required No Informationntervention | 2018-11-06 |