MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-30 for ACCUPORT 414.502 manufactured by Zimmer Knee Creations, Inc..
[134460955]
Cannulated drill was left in the right femur condyle for 8 minutes after allograft was injected per directions of scp knee kit. The surgeon took out the cannulated drill bit with a needle holder, 15mm of the tip of the cannulated drill bit broke off and was unintentionally retained in the right femur condyle. After an x-ray was taken, the surgeon discovered that the cannulated drill bit was unintentionally retained in the right femur.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8288276 |
| MDR Report Key | 8288276 |
| Date Received | 2019-01-30 |
| Date of Report | 2019-01-25 |
| Date of Event | 2019-01-24 |
| Report Date | 2019-01-25 |
| Date Reported to FDA | 2019-01-25 |
| Date Reported to Mfgr | 2019-01-30 |
| Date Added to Maude | 2019-01-30 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | ACCUPORT |
| Generic Name | KIT BONE GRAFT DELIVERY |
| Product Code | FGY |
| Date Received | 2019-01-30 |
| Model Number | 414.502 |
| Catalog Number | 414.502 |
| Lot Number | KC05431 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER KNEE CREATIONS, INC. |
| Manufacturer Address | 841 SPRINGDALE DRIVE EXTON PA 19341 US 19341 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-30 |