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 2018-03-07 for TRAUMACEM(TM) V+ SYRINGE KIT - STERILE 03.702.150S manufactured by Wrights Lane Synthes Usa Products Llc.
[101772406]
Additional narrative: patient information was not provided for reporting. Device is an instrument and is not implanted / explanted. (b)(4). The device was received and the product evaluation is in progress. No conclusion can be drawn. 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
[101772407]
It was report that the patient underwent original surgery on (b)(6) 2018 for treatment of a femur fracture. Patient was implanted with one (1) tfna trochanteric fixation nail advanced, (1) helical blade and two (2) distal locking screws. Intraoperatively, after the nail had been implanted, at the back table, that surgeon prepared the ttaumacem v cement. It was reported that the injector was not filling the syringes initially. It would not turn properly, and the hole where the stop connects was trapped. The doctor cleared the hole, that was jammed, and pmma slowly released into syringes. By this time the viscosity was too thick to send down injection cannula. Surgeon was unable to inject the cement mix through to the helical blade implant. Surgeon chose not to include the cement mix that was ordinally planned for in this procedure. Surgery was completed successfully with 5-minute time delay. Patient was reported in stable condition. Concomitant device reported: traumacem (tm) v+ injection cannula for tfna - sterile (item # 03. 702. 121s, lot # aqy317, quantity 1). This report is for one (1) traumacem(tm) v+ syringe kit - sterile. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[119058953]
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
| Report Number | 2939274-2018-50916 |
| MDR Report Key | 7321120 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-03-07 |
| Date of Report | 2018-02-07 |
| Date of Event | 2018-02-07 |
| Date Mfgr Received | 2018-05-14 |
| Device Manufacturer Date | 2017-07-10 |
| Date Added to Maude | 2018-03-07 |
| 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 SELZACH |
| Manufacturer Street | BOHACKERWEG 5 |
| Manufacturer City | SELZACH 2545 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 2545 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRAUMACEM(TM) V+ SYRINGE KIT - STERILE |
| Generic Name | DISPENSER, CEMENT |
| Product Code | KIH |
| Date Received | 2018-03-07 |
| Returned To Mfg | 2018-02-28 |
| Model Number | 03.702.150S |
| Catalog Number | 03.702.150S |
| Lot Number | 7032671 |
| 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 | 1. Required No Informationntervention | 2018-03-07 |