MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2002-07-29 for HELOTOME 10 MM 22-0010 manufactured by Cortek, Inc..
[268801]
Two helotome blades broke during surgery in one pt. The blades were retrieved and the procedure completed. The torque limiting handle was not used during the cut as described in the surgical technique allowing the cut to overload the helotome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226193-2002-00008 |
| MDR Report Key | 408592 |
| Report Source | 05 |
| Date Received | 2002-07-29 |
| Date of Report | 2002-07-23 |
| Date of Event | 2001-08-23 |
| Date Mfgr Received | 2001-08-23 |
| Date Added to Maude | 2002-08-06 |
| 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 Contact | ROBERT ZOLETTI |
| Manufacturer Street | 980 WASHINGTON ST SUITE 328 |
| Manufacturer City | DEDHAM MA 02026 |
| Manufacturer Country | US |
| Manufacturer Postal | 02026 |
| Manufacturer Phone | 7814070020 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HELOTOME |
| Generic Name | OSTEOTOME |
| Product Code | GFI |
| Date Received | 2002-07-29 |
| Model Number | 10 MM |
| Catalog Number | 22-0010 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 397584 |
| Manufacturer | CORTEK, INC. |
| Manufacturer Address | 980 WASHINGTON ST., SUITE 328 DEDHAM MA 02026 US |
| Baseline Brand Name | HELOTOME |
| Baseline Generic Name | OSTEOTOME |
| Baseline Model No | 10 MM |
| Baseline Catalog No | 22-0010 |
| Baseline Device Family | HELOTOME |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-07-29 |