MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07,08 report with the FDA on 1997-08-20 for ACUFEX MOSAICPLASTY 4.5MM TUBULAR CHISEL 7207097 manufactured by Smith & Nephew, Inc..
[80828]
Distal end of bone chisel broke off in knee. Broken piece was embedded to prevent impingement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219602-1997-00071 |
| MDR Report Key | 114711 |
| Report Source | 01,05,06,07,08 |
| Date Received | 1997-08-20 |
| Date of Event | 1997-05-15 |
| Date Facility Aware | 1997-05-15 |
| Date Mfgr Received | 1997-07-23 |
| Device Manufacturer Date | 1996-05-01 |
| Date Added to Maude | 1997-08-25 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACUFEX MOSAICPLASTY 4.5MM TUBULAR CHISEL |
| Generic Name | BONE CHISEL |
| Product Code | KDG |
| Date Received | 1997-08-20 |
| Returned To Mfg | 1997-08-08 |
| Model Number | NA |
| Catalog Number | 7207097 |
| Lot Number | 196 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 112605 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 130 FORBES BOULEVARD MANSFIELD MA 02048 US |
| Baseline Brand Name | MOSAIC PLASTY-TUBULAR CHISEL 4.5MM |
| Baseline Generic Name | BONE CHISEL |
| Baseline Model No | * |
| Baseline Catalog No | 7207097 |
| Baseline ID | * |
| Baseline Device Family | MOSAICPLASTY |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K962789 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-08-20 |