MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-15 for SIDE DELIVERY CANNULA N/A 414.502 manufactured by Zimmer Knee Creations, Inc..
[55126035]
(b)(6) was contacted and asked to recount his discussion with the surgeon. It was reported that the surgeon drilled the accuport? Into the patient without difficulty. When he tried to inject, he was met with a lot of resistance. The cannula was fully removed before being placed back in the body, through the same portal, and re directed. In its new position, the surgeon was able to inject the desired amount of accufill? Bsm. After injecting, the surgeon tried to replace the stylus. He was successful for the most part, but was unable to get the two pieces to click together. The surgeon left the accuport? Cannula as it was and returned to arthroscopy. In the process of flexing and extending the knee, the surgeon reported that he heard a popping sound. When he removed the accuport? Cannula, after completing the arthroscopy, he found that it had broken near the tip. The surgeon chose to not try to retrieve the broken part and instead leave it in the body. It is unknown how much arthroscopy was done before or after the injection of accufill? Bsm or where the break in the cannula occurred. There was no indication of extravasation or long term harm to the patient. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[55126036]
Broken cannula tip inside bone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008812173-2016-00017 |
| MDR Report Key | 5953122 |
| Date Received | 2016-09-15 |
| Date of Report | 2017-10-20 |
| Date of Event | 2016-07-27 |
| Date Mfgr Received | 2016-08-17 |
| Date Added to Maude | 2016-09-15 |
| 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 | 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 | SIDE DELIVERY CANNULA |
| Generic Name | CANNULA |
| Product Code | FGY |
| Date Received | 2016-09-15 |
| Model Number | N/A |
| Catalog Number | 414.502 |
| Lot Number | KC02901 |
| ID Number | N/A |
| 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 | 2016-09-15 |