MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-08-23 for ACCUPORT SIDE-TARGETED CANNULA (SELF-DRILLING) 307.032 76038-01M manufactured by Knee Creations, Llc.
[3718094]
The side-targeted cannula broke at the midpoint of the third fenestration. The surgical technique was free hand pin placement with fluoroscopy with power aided cannula insertion and extraction. The trocar was removed and the accufill was injected. There was a 3 minute waiting period for accufill to cure. The cannula was then removed by hand. The surgeon discovered the cannula tip was broken when he placed the cannula on the back surgery table. He verified the tip was still in the patient using fluoroscopy. The surgeon did not attempt to recover the broken tip of the cannula from the patient.
Patient Sequence No: 1, Text Type: D, B5
[11114834]
No retrieval device was available from the complaint case for examination. Further investigation was done with the surgeon and representative present during the case. Surgery was performed with surgical drill without use of the instrument guide. During insertion the pin was partially backed out and then redirected to new trajectory while in the bone thus some bending likely occurred during insertion. It was reported that after injection, the cannula was being removed by hand and during the time the operating time tech nurse unknowingly manipulated the knee into flexion. Only after the procedure at the back table was it discovered that the tip was missing from the cannula.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008812173-2013-00003 |
| MDR Report Key | 3375820 |
| Report Source | 07 |
| Date Received | 2013-08-23 |
| Date of Report | 2013-07-25 |
| Date Mfgr Received | 2013-07-25 |
| Device Manufacturer Date | 2013-04-01 |
| Date Added to Maude | 2013-11-21 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DAVID NICHOLS |
| Manufacturer Street | 900 AIRPORT RD SUITE 3B |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 4848878891 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCUPORT SIDE-TARGETED CANNULA (SELF-DRILLING) |
| Generic Name | NONE |
| Product Code | FGY |
| Date Received | 2013-08-23 |
| Model Number | 307.032 |
| Catalog Number | 76038-01M |
| Lot Number | 26894 |
| Device Expiration Date | 2018-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KNEE CREATIONS, LLC |
| Manufacturer Address | 900 AIRPORT RD SUITE 3B WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-23 |