MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-06-15 for HALL POWERPRO PIN DRIVER PRO3333 * manufactured by Linvatec Corp.
[361116]
During use of the hall powerpro pin driver to place a pin in a pt's hip, the inner housing that holds the pin broke apart. When this occurred, sharp metal shards shot out the back of the wire driver/drill. Three of the pieces where retrieved, the fourth was not. This case was a percutaneous case with very small incisions and because the other 3 pieces shot out on the floor, it appears that the missing piece was not in the pt. Fluoroscopy/x-ray was being used to guide the placement of the orthopedic hardware and showed no evidence of foreign body in the pt. This pin driver was brand new from the co and this was its first day of use. User facility has had repeated problems with reliability of this product. The co professes that user facility seem to be the only hosp in the area that is having these problems and has reported that no other facilities have reported issues/concerns.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 533873 |
| MDR Report Key | 533873 |
| Date Received | 2004-06-15 |
| Date of Report | 2004-06-09 |
| Date of Event | 2004-05-24 |
| Report Date | 2004-06-09 |
| Date Reported to FDA | 2004-06-10 |
| Date Added to Maude | 2004-07-14 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HALL POWERPRO PIN DRIVER |
| Generic Name | SURGICAL PIN DRIVER |
| Product Code | GFC |
| Date Received | 2004-06-15 |
| Model Number | PRO3333 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 523141 |
| Manufacturer | LINVATEC CORP |
| Manufacturer Address | 11311 CONCEPT BOULEVARD LARGO FL 337734908 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-06-15 |