MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-04-13 for CODMAN 7 INCH STERNAL CLASSIC PLUS NEEDLE HOLDER # 36-2025 * manufactured by Symmetry Surgical (codman).
[2607532]
The tip of the needle driver fell off during routine use. The problem was identified at the time and the surgeon retrieved the fractured tip without impact to patient. ======================manufacturer response for needle driver, codman 7 inch sternal classic plus needle holder # 36-2025 (per site reporter)======================the analysis is being arranged.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2538020 |
| MDR Report Key | 2538020 |
| Date Received | 2012-04-13 |
| Date of Report | 2012-04-04 |
| Report Date | 2012-04-04 |
| Date Reported to FDA | 2012-04-13 |
| Date Added to Maude | 2012-04-17 |
| 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 | CODMAN 7 INCH STERNAL CLASSIC PLUS NEEDLE HOLDER # 36-2025 |
| Generic Name | NEEDLE DRIVER |
| Product Code | MJG |
| Date Received | 2012-04-13 |
| Model Number | CODMAN 7 INCH STERNAL CLASSIC PLUS NEEDLE HOLDER # |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYMMETRY SURGICAL (CODMAN) |
| Manufacturer Address | 325 PARAMOUNT DR. RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-13 |