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 2017-02-16 for 11MM TI CANNULATED FEMORAL NAIL 400MM-STERILE 474.141S manufactured by Synthes Monument.
[67593214]
Device used for treatment, not diagnosis. Additional product code: hty. (b)(4). Device is not expected to be returned for manufacturer review/investigation. Concomitant devices reported: ti locking bolt (part numbers: 459. 36, 459. 42, 459. 46, 459. 56; quantity: 4). Device history records review was conducted. Dhr review for part #474. 141s, lot #5469939. Release to warehouse date: 11-apr-2007. Expiration date: 29-feb-2016. Manufactured by synthes (b)(4). No ncrs were generated during production. Review of the device history record showed that there were no issues during the manufacture of this product that would contribute to this complaint condition. 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
[67593215]
It was reported that patient had a femoral nail implanted in (b)(6) 2007. On (b)(6), 2017 patient had nail removed due to hypertrophic nonunion. Patient was revised with a larger femoral nail. There was no delay in surgery and procedure completed successfully. There is 1 device in this complaint concomitant devices reported: ti locking bolt (part numbers: 459. 36, 459. 42, 459. 46, 459. 56; lot number unknown; quantity: 4). This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[69039166]
Patient code (b)(4) used to capture additional medical/surgical intervention required. The investigation could not be completed; no conclusion could be drawn, as no product was received. Initially reported concomitant parts were deemed reportable parts and medwatches are submitted these additional parts. (b)(4). 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
[69039167]
This is report 1 of 5 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1719045-2017-10113 |
| MDR Report Key | 6336179 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-02-16 |
| Date of Report | 2017-01-19 |
| Date Mfgr Received | 2017-03-02 |
| Device Manufacturer Date | 2007-04-11 |
| Date Added to Maude | 2017-02-16 |
| 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 MONUMENT |
| Manufacturer Street | 1051 SYNTHES AVE |
| Manufacturer City | MONUMENT CO 80132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 11MM TI CANNULATED FEMORAL NAIL 400MM-STERILE |
| Generic Name | IMPLANT, FIXATION DEVICE, SPINAL |
| Product Code | JDN |
| Date Received | 2017-02-16 |
| Catalog Number | 474.141S |
| Lot Number | 5469939 |
| Device Expiration Date | 2016-02-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES MONUMENT |
| Manufacturer Address | 1051 SYNTHES AVE MONUMENT CO 80132 US 80132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-02-16 |