MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-24 for STRYKER CORE SUMEX DRILL manufactured by Stryker Instruments.
[115080961]
Patient in surgery for lumbar laminectomy. Surgeon using a stryker core sumex drill. The drill became warm in surgeon's hand. The drill would then only work in reverse and the staff were unable to remove the drill bit from the drill. The drill was taken out of service and exchanged for a new drill. Problem was reported to the clinical leaders of the operating room and the manager of central sterile. The item was sent to central sterile to be returned to the manufacturer. No harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078575 |
| MDR Report Key | 7717844 |
| Date Received | 2018-07-24 |
| Date of Report | 2018-07-19 |
| Date of Event | 2018-07-19 |
| Date Added to Maude | 2018-07-25 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Brand Name | STRYKER CORE SUMEX DRILL |
| Generic Name | DRIVER, WIRE, AND BONE DRILL, MANUAL |
| Product Code | DZJ |
| Date Received | 2018-07-24 |
| Lot Number | 1109600083 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-24 |