MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-14 for BIT, DRILL 873-007 manufactured by Medtronic Sofamor Danek Usa, Inc.
[183481043]
Product was not returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183481044]
It was reported that the patient presented with odontoid process fracture; and anterior screw fixation at c2. Intra-op, the drill bit broke at the time of creating the pilot hole. After the guide wire was placed using the guide, the drill bit was connected with the hospital power. Then drilling was performed while checking the image. Bone quality did not seem so hard. When the drill was pulled back after advancing to the desired depth, it was noticed that the drill tip broke off at the base of the blade; and the broken tip was remaining in the vertebral body. It was confirmed that the drill tip protruded about 5 mm ahead of the vertebral body under the image and visual observation. Skin incision was widened a little and the broken tip was removed from the patient. It was confirmed by image that there were no fragments remaining in the patient body. Later, the guide wire was inserted, placed and screw insertion was performed. The procedure was successfully completed. There was a delay of less than 60 minutes in overall procedure time. No patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2020-00305 |
| MDR Report Key | 9833064 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-14 |
| Date of Report | 2020-03-14 |
| Date of Event | 2020-02-13 |
| Date Mfgr Received | 2020-02-13 |
| Device Manufacturer Date | 2018-11-15 |
| Date Added to Maude | 2020-03-14 |
| 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 | STACIE ZIEMBA |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | MEDTRONIC SOFAMOR DANEK USA, INC |
| Manufacturer Street | 4340 SWINEA RD |
| Manufacturer City | MEMPHIS TN 38118 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38118 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIT, DRILL |
| Generic Name | BIT, DRILL |
| Product Code | HTW |
| Date Received | 2020-03-14 |
| Model Number | NA |
| Catalog Number | 873-007 |
| Lot Number | NG18H019 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SOFAMOR DANEK USA, INC |
| Manufacturer Address | 4340 SWINEA RD MEMPHIS TN 38118 US 38118 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-14 |