MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-01 for ACCUPORT N/A 402.202 manufactured by Zimmer Knee Creations, Inc..
[49391571]
The surgeon was using the subchondroplasty system in the proximal medial tibia. After the last of the accufill was injected, the trocar was put back into the accuport. The surgeon then left the entire accuport in while the accufill was hardening and he moved on to arthroscopic portion of the case. While performing the scope, he bumped the cannula with his hand. It broke at the third hole from the tip. The accuport was removed, and an attempt was made to remove the remaining tip of the accuport. The surgeon determined it would cause too much damage to the bone to remove, so the decision was made to leave it in the bone and finish the procedure.
Patient Sequence No: 1, Text Type: N, H10
[49391572]
Surgeon bumped the cannula with his hand and broke at the third hole from the tip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008812173-2016-00011 |
| MDR Report Key | 5765000 |
| Date Received | 2016-07-01 |
| Date of Report | 2016-06-03 |
| Date of Event | 2016-06-03 |
| Date Mfgr Received | 2016-06-02 |
| Device Manufacturer Date | 2016-05-16 |
| Date Added to Maude | 2016-07-01 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. VICTOR KRONE |
| Manufacturer Street | 841 SPRINGDALE DRIVE |
| Manufacturer City | EXTON PA 19341 |
| Manufacturer Country | US |
| Manufacturer Postal | 19341 |
| Manufacturer Phone | 4848794224 |
| 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 |
| Generic Name | CANNULA |
| Product Code | FGY |
| Date Received | 2016-07-01 |
| Model Number | N/A |
| Catalog Number | 402.202 |
| Lot Number | N/A |
| ID Number | N/A |
| Device Expiration Date | 2018-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2016-07-01 |