MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2015-07-08 for 10MM TI CANNULATED FEMORAL NAIL 320MM-STERILE 474.032S manufactured by Synthes Monument.
[6066017]
It was reported that a patient underwent a hardware removal procedure on (b)(6) 2015 due to persistent pain (without infection) of the left hip. During the procedure, the following intact devices were removed: an antegrade femoral nail, an end cap, and three (3) 5. 0mm locking screws. The procedure was completed successfully with a one (1) minute surgical delay due to a bent screwdriver. At this time, the patient has not been revised to a new device. This report is 1 of 3 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[14249830]
Additional patient information: patient height was reported as (b)(6). Patient initials are (b)(6). The patient? S exact weight is reported as (b)(6). (expiry date): june 2010. The original implant procedure occurred on an unknown date approximately ten (10) years ago. The complaint part was returned to the patient and is not available for return. The investigation could not be completed; no conclusion could be drawn as no product was received. Device history review: manufacturing location: monument - manufacturing date: june 20, 2001 - expiration date: june 2010. No non-conformance reports were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. Device 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
[29625165]
A corrected device history record review was completed: part number: 474. 032s. Lot number: 4265721. Raw material number: 4122647. Manufacture date: 19june2001. Expiration date: 01june2010. A review of depuy synthes monument device history records for manufacturing revealed no complaint related issues. 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 | 1719045-2015-10435 |
| MDR Report Key | 4898657 |
| Report Source | 05,07 |
| Date Received | 2015-07-08 |
| Date of Report | 2015-06-29 |
| Date Mfgr Received | 2015-08-03 |
| Device Manufacturer Date | 2001-06-19 |
| Date Added to Maude | 2015-07-08 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LINDA PLEWS |
| 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 | 10MM TI CANNULATED FEMORAL NAIL 320MM-STERILE |
| Generic Name | IMPLANT, FIXATION DEVICE, SPINAL |
| Product Code | JDN |
| Date Received | 2015-07-08 |
| Catalog Number | 474.032S |
| Lot Number | 4265721 |
| Device Expiration Date | 2010-06-01 |
| 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 | 2015-07-08 |