MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-07-15 for NITINOL GUIDE PIN * manufactured by Arthrex, Inc..
[20884476]
Medical record reviewed 7-8-98. Per operative report: "the nitinol guide pin broke off with approximately 1 inch of the pin remaining in the femoral tunnel. The large portion of the pin was removed. The graft was backed out slightly which exposed the broken pin fragment. This was grasped with a slessinger grasper and brought out of the knee. The pin was carefully inspected and found to be completely intact with all fragments removed. " surgeon stated "technique was reason for breaking. " no apparent injury to pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1014184 |
| MDR Report Key | 177691 |
| Date Received | 1998-07-15 |
| Date of Report | 1998-07-08 |
| Date of Event | 1998-06-25 |
| Date Added to Maude | 1998-07-20 |
| 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 |
| 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 | NITINOL GUIDE PIN |
| Generic Name | GUIDE PIN |
| Product Code | HXY |
| Date Received | 1998-07-15 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | AR 1254 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 172780 |
| Manufacturer | ARTHREX, INC. |
| Manufacturer Address | 2885 SOUTH HORSESHOE DR NAPLES FL 34104 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-07-15 |