MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2014-07-23 for CODMAN OLIVERCRONA-GIGLI SAW 75-1020 manufactured by Symmetry Surgical.
[4963680]
During a tibial osteotomy for the correction of the lower limb, during the procedure the gigli saw showed fraying and subsequently broke. Some fragments/filaments of the saw have penetrate inside the bone. No pt adverse consequences have been reported. The event happened in italy.
Patient Sequence No: 1, Text Type: D, B5
[12213229]
Device was not returned for evaluation. Method - a device from the same lot of actual device involved in incident was evaluated. Result - visual examination of device. No conclusion can be drawn. Conclusion - use of device cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007208013-2014-00004 |
| MDR Report Key | 4203818 |
| Report Source | 01,08 |
| Date Received | 2014-07-23 |
| Date of Report | 2014-07-22 |
| Date of Event | 2014-04-18 |
| Date Mfgr Received | 2014-06-03 |
| Date Added to Maude | 2014-11-06 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHRIS SMITH |
| Manufacturer Street | 3034 OWEN DR |
| Manufacturer City | ANTIOCH TN |
| Manufacturer Country | US |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CODMAN OLIVERCRONA-GIGLI SAW |
| Generic Name | GIGLI SAW |
| Product Code | DWH |
| Date Received | 2014-07-23 |
| Model Number | 75-1020 |
| Catalog Number | 75-1020 |
| Lot Number | 1792011 |
| ID Number | 00887482030158 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYMMETRY SURGICAL |
| Manufacturer Address | ANTIOCH TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-23 |