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 2018-11-30 for TRAUMACEM(TM) V+ INJECTION CANNULA FOR TFNA - STERILE 10001851US 03.702.121S manufactured by Wrights Lane Synthes Usa Products Llc.
[128960460]
Device is not expected to be returned for manufacturer review/investigation. Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer. Additionally, device history records review has been requested. 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
[128960461]
It was reported that on (b)(6) 2018, during an unknown procedure, after distal screw was placed into trochanteric femoral nail advanced (tfna), the cannula was stuck in the femoral head due to the cement setting. The tip of the cannula broke off in the helical blade. The traumacem cannula was left in the femoral head after cement was injected. It is unknown if there was a surgical delay. Procedure and patient outcome are unknown. Concomitant devices: screw (part unknown, lot unknown, quantity 1). Helical blade (part unknown, lot unknown, quantity 1). This report is for one (1) traumacem(tm) v+ injection cannula for tfna - sterile. This is report 1 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2018-55215 |
| MDR Report Key | 8121463 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-11-30 |
| Date of Report | 2018-11-14 |
| Date of Event | 2018-11-14 |
| Date Mfgr Received | 2018-12-26 |
| Device Manufacturer Date | 2018-02-16 |
| Date Added to Maude | 2018-11-30 |
| 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 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+ INJECTION CANNULA FOR TFNA - STERILE |
| Generic Name | DISPENSER, CEMENT |
| Product Code | KIH |
| Date Received | 2018-11-30 |
| Model Number | 10001851US |
| Catalog Number | 03.702.121S |
| Lot Number | ARN185 |
| 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 | 2018-11-30 |