MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-20 for CARDINAL HEALTH SNECGSPAUD manufactured by Cardinal Healthcare Corp.
[86743287]
Patient Sequence No: 1, Text Type: N, H10
[86743288]
Patient was in or for a l4-5 anterior lumbar inter-body fusion performed by dr. As the surgeon was using #10 schwann morton knife blade on a long handle to dissect tissue off the vertebrae column, the knife blade broke in two pieces from the knife handle. This resulted with one piece falling to the side of the vertebrae where the surgeon had to remove tissue and suck blood carefully in order to identify the blade end that broke and safely remove it from the operating field. The other part of the blade remained on the knife handle and was safely removed from the field as well. Procedure was completed with no further incidents, knife blades from that spine pack from vendor schwann morton were all removed form the operating field and back table and replaced with a different manufacturer's knife blades. Vendor notified immediately upon incident reported by or nurse in the operating room. Manufacturer response for surgical disposable pack, pack surgical spine latex free (per site reporter) ====================== email and phone call to area representative who filed the complaint with the company. The company removed all knife blades from schwann morton from this facilities' surgical spine packs and replaced them with a different manufacturer's knife blades per facility request, the replacement blade was requested to be thicker and sturdier to prevent breaking. Company also, notified facility that they would file an incident report with fda for the knife blades.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6878649 |
| MDR Report Key | 6878649 |
| Date Received | 2017-09-20 |
| Date of Report | 2017-08-21 |
| Date of Event | 2017-07-25 |
| Report Date | 2017-08-21 |
| Date Reported to FDA | 2017-08-21 |
| Date Reported to Mfgr | 2017-08-21 |
| Date Added to Maude | 2017-09-20 |
| 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 |
| 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 | CARDINAL HEALTH |
| Generic Name | NEUROLOGICAL TRAY |
| Product Code | OJG |
| Date Received | 2017-09-20 |
| Model Number | SNECGSPAUD |
| Catalog Number | SNECGSPAUD |
| Lot Number | 727298 |
| ID Number | #10 BLADE SCHWANN MORTON |
| Device Expiration Date | 2019-01-01 |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Age | 1 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTHCARE CORP |
| Manufacturer Address | 785 FORT MILL HWY. FORT MILL SC 29707 US 29707 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-20 |