MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-02 for DYNJ0397191T manufactured by Medline Industries Inc..
[145771490]
It was reported that during a spinal fusion, a #11 surgical blade (taken from a neuro pack) broke in half. At the time of the incident, the surgeon was reportedly cutting the disc in the spine when the blade broke in half off of the scalpel. The surgeon was able to remove the blade; however the removal added an additional 20-30 minutes and x-rays were required to remove the sharp pointed end out of the patient's spine. Per the facility's report, all pieces of the blade were successfully retrieved without further incident. No impact to the patient, the staff, or the procedure was reported. There was no serious injury or follow-up care reported related to the event. General anesthesia was used; however, there was no report of any adverse patient consequence and no effect on the patient's stability as a result of the incident. Due to the reported event and required medical intervention, this medwatch is being filed. The sample was not returned to the manufacturer for evaluation. A root cause could not be determined at this time. No additional information is available. If additional information becomes available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[145771491]
It was reported that the surgical blade broke in half. The blade was successfully retrieved without further intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423395-2019-00007 |
| MDR Report Key | 8475203 |
| Date Received | 2019-04-02 |
| Date of Report | 2019-04-02 |
| Date of Event | 2019-02-28 |
| Date Mfgr Received | 2019-03-06 |
| Date Added to Maude | 2019-04-02 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | KAREN TRUTSCH |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | NEURO PACK |
| Product Code | OJG |
| Date Received | 2019-04-02 |
| Catalog Number | DYNJ0397191T |
| Lot Number | UNK |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-04-02 |