MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-13 for ACCUPORT SIDE DELIVERY CANNULA N/A 414.502 manufactured by Zimmer Knee Creations, Inc..
[65219244]
The sales rep, alex wirlo, and the surgeon, dr. (b)(6), were contacted to collect information regarding this complaint. The patient was an older woman with relatively soft bone and there were no injection issues during the surgery. Dr. (b)(6) drilled the side delivery accuport? Cannula into the patient? S distal femur and injected the desired amount of bone substitute material (bsm). He then plunged the stylus into the cannula to force the remaining bsm into the bone. The stylus was then removed. The surgeon proceeded to flex the knee to scope the joint. When the scoping was complete, he extended the leg and heard a? Popping? Sound. The surgeon believes that the accuport? Cannula broken at the exterior surface of the cortical bone, which was about 5mm proximal to the 3rd fenestration. The provided c-arm image indicates that the instrument broke at it's 3rd fenestration. The surgeon evaluated the situation and determined that it would be more detrimental to the patient to try to retrieve the broken tip. The surgeon chose to leave the piece in the patient? S body. As the part was not returned, and the investigator was not at the surgery to observe, the definitive cause of this failure cannot be determined. It is likely that the lack of stylus and the flexing of the knee contributed to the instrument? S failure.
Patient Sequence No: 1, Text Type: N, H10
[65219265]
Breakage-tip cannula in the femur.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008812173-2017-00003 |
| MDR Report Key | 6248942 |
| Date Received | 2017-01-13 |
| Date of Report | 2017-10-20 |
| Date of Event | 2016-12-16 |
| Date Mfgr Received | 2016-12-19 |
| Date Added to Maude | 2017-01-13 |
| 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 | MS. SHARI BAILEY |
| Manufacturer Street | 841 SPRINGDALE DRIVE |
| Manufacturer City | EXTON PA 19341 |
| Manufacturer Country | US |
| Manufacturer Postal | 19341 |
| Manufacturer Phone | 4848794543 |
| Manufacturer G1 | ZIMMER KNEE CREATIONS, INC. |
| Manufacturer Street | 841 SPRINGDALE DRIVE |
| Manufacturer City | EXTON PA 19341 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ACCUPORT SIDE DELIVERY CANNULA |
| Generic Name | CANNULA |
| Product Code | FGY |
| Date Received | 2017-01-13 |
| Model Number | N/A |
| Catalog Number | 414.502 |
| Lot Number | KC03474 |
| ID Number | N/A |
| Device Expiration Date | 2019-11-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Other | 2017-01-13 |