MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2005-09-22 for NEFF FEMOROTIBIAL NAIL DRILL GUIDE 00855321183 manufactured by Zimmer, Inc..
[433236]
It is reported that the device was used in surgery in 2005. The drill guide had too much sideways toggle to be accurate while drilling the proximal anterior tibia for final morse taper lock down. Screws were inserted cross-threaded and the nail separated. Revision surgery was performed 5 days late.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1822565-2005-00184 |
| MDR Report Key | 636919 |
| Report Source | 05,08 |
| Date Received | 2005-09-22 |
| Date of Report | 2005-08-08 |
| Date of Event | 2005-08-03 |
| Date Facility Aware | 2005-08-08 |
| Report Date | 2005-08-08 |
| Date Mfgr Received | 2005-08-24 |
| Device Manufacturer Date | 1999-09-01 |
| Date Added to Maude | 2005-09-27 |
| 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 | CONNIE MORGAN |
| Manufacturer Street | P.O. BOX 708 |
| Manufacturer City | WARSAW IN 465810708 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810708 |
| Manufacturer Phone | 5743724269 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEFF FEMOROTIBIAL NAIL DRILL GUIDE |
| Generic Name | TRAUMA INSTRUMENT |
| Product Code | FZH |
| Date Received | 2005-09-22 |
| Returned To Mfg | 2005-08-24 |
| Model Number | NA |
| Catalog Number | 00855321183 |
| Lot Number | 34987600 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 626453 |
| Manufacturer | ZIMMER, INC. |
| Manufacturer Address | P.O. BOX 708 WARSAW IN 465810708 US |
| Baseline Brand Name | NEFF FEMOROTIBIAL NAIL TIBIAL DRILL GUIDE |
| Baseline Generic Name | TRAUMA INSTRUMENT |
| Baseline Model No | NA |
| Baseline Catalog No | 00855321183 |
| Baseline ID | NA |
| Baseline Device Family | NEFF FEMOROTIBIAL NAIL |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2005-09-22 |