MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for EVOS SMALL 2.5MM DRILL W/AO QC LONG 71175022 manufactured by Smith & Nephew, Inc..
[187076175]
It was reported that during the procedure the fracture was reduced and bone void filler was used to fill the defect in the proximal tibia. Several k-wires were used to hold the fracture together and then a lateral proximal tibia plate was applied using more k-wires to hold it in place. Then two screws were placed into the plate. At that point the 2. 5mm drill was used again to prepare for another screw. While drilling the drill bit encountered a couple of the k-wires (? Pin traffic? ) while trying to get the perfect trajectory for the next screw. At that point the tip of the drill bit broke off inside the proximal tibia. Several attempts were made with multiple different instruments to try and recover the broken drill bit tip. Eventually it was determined by the surgeons that more harm would be caused to the patient by trying to retrieve the drill bit tip than leaving it in the patients tibia. Many x-rays were taken to confirm that the drill bit tip was not in the knee joint space and to confirm that it would not cause any harm to the patient. The case was completed with an approximate 5-minute delay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020279-2020-01103 |
| MDR Report Key | 9903428 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 1901-01-01 |
| Date Mfgr Received | 2020-03-05 |
| Date Added to Maude | 2020-03-31 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR. SARAH FREESTONE |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 0447940038 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38116 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EVOS SMALL 2.5MM DRILL W/AO QC LONG |
| Generic Name | INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWRED MOTOR AND ACCESSORY/ATTACHMNT |
| Product Code | HWE |
| Date Received | 2020-03-31 |
| Model Number | 71175022 |
| Catalog Number | 71175022 |
| Lot Number | UNKNOWN/UNREADABLE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 1450 BROOKS ROAD MEMPHIS TN 38116 US 38116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |