MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2000-10-06 for ISOLA 2050-50 manufactured by Depuy Acromed, Inc..
[200124]
Depuy acromed rec'd a broken isola hex driver. The tip of the instrument broke off into the set screw during final tightening. The tip still remains in implant. A chemical analysis was performed on the driver and it conformed to 420-grade stainless steel. A rockwell hardness test was also performed on the driver and the driver conformed to specs of 54-56 hrc. The cause of the broken tip is usually due to over-tightening during screw insertion. These devices are extremely small, and will fracture if over-torqued. Care must be taken not to over-torgue these drivers. A torque wrench is available for those physicians having difficulty with these types of events. No further action is required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2000-00021 |
| MDR Report Key | 299511 |
| Report Source | 07 |
| Date Received | 2000-10-06 |
| Date of Report | 2000-10-06 |
| Date Mfgr Received | 2000-09-06 |
| Date Added to Maude | 2000-10-12 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 027670350 |
| Manufacturer Country | US |
| Manufacturer Postal | 027670350 |
| Manufacturer Phone | 5088808100 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ISOLA |
| Generic Name | HEX DRIVER |
| Product Code | GFC |
| Date Received | 2000-10-06 |
| Model Number | NA |
| Catalog Number | 2050-50 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 289909 |
| Manufacturer | DEPUY ACROMED, INC. |
| Manufacturer Address | 325 PARAMOUNT DR. RAYNHAM MA 027670350 US |
| Baseline Brand Name | ISOLA |
| Baseline Generic Name | HEX DRIVER |
| Baseline Model No | NA |
| Baseline Catalog No | 2050-50 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-10-06 |