MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 2006-09-13 for INTERNAL SCREWDRIVER * 119840 manufactured by Newdeal S.a..
[20620138]
The orthopedic foot and ankle specialist physician performed an arthrodesis in 2006, using the kalix set. When he tried using the internal screwdriver (product id #119-840), it would not function properly. The physician noted that the distal end of the device appears to have sheared off. The screwdriver could not seat properly within the implant and allow the surgeon to expand the arthrodesis. The physician tried to get it to work by removing the external screwdriver so that he would have easier access to the implant and visual identification. This attempt forced the metallic part of the implant all the way through the implant. The physician was able to remove all pieces of the 11mm implant (product id #140-011). The physician then tried to salvage the procedure by using a free-er, and the unscrewer from the kalix set. The physician used a new 11mm implant to complete the surgery. The revision worked and the physician was satisfied with the end result that he achieved. The kalix set is available for return and evaluation.
Patient Sequence No: 1, Text Type: D, B5
[20826868]
To date, the device has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615741-2006-00026 |
| MDR Report Key | 759759 |
| Report Source | 06,08 |
| Date Received | 2006-09-13 |
| Date of Report | 2006-09-08 |
| Date Mfgr Received | 2006-08-08 |
| Date Added to Maude | 2006-09-15 |
| 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 | 0 |
| Manufacturer Contact | DANIEL-GARY HOLDERMAN |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362469 |
| Manufacturer G1 | NEWDEAL S.A. |
| Manufacturer Street | 10, PLACE D'HELVETIE |
| Manufacturer City | LYON 69006 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 69006 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTERNAL SCREWDRIVER |
| Generic Name | KALIX ASSOCIATED INSTRUMENTS |
| Product Code | KXX |
| Date Received | 2006-09-13 |
| Model Number | * |
| Catalog Number | 119840 |
| Lot Number | D2TR |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 747678 |
| Manufacturer | NEWDEAL S.A. |
| Manufacturer Address | * LYON FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-09-13 |