MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-07-03 for * 391.80 manufactured by Synthes.
[65187]
Piece of wire twister "metallic insert" on device broke off from instrument. Noticed on x-ray in recovery postop. # on instrument 391. 80. As of 6/19/97 - no complications. Plan to extract fragment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1011634 |
| MDR Report Key | 103078 |
| Date Received | 1997-07-03 |
| Date of Report | 1997-06-18 |
| Date of Event | 1997-05-27 |
| Date Added to Maude | 1997-07-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | "WIRE TWISTER" |
| Product Code | HXS |
| Date Received | 1997-07-03 |
| Model Number | 391.80 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 101427 |
| Manufacturer | SYNTHES |
| Manufacturer Address | 1680 RUSSELL RD. PAOLI PA 19301 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-07-03 |