MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-07 for ACCUPORT DELIVERY CANNULA N/A 514.502 manufactured by Zimmer Knee Creations, Inc..
[57320543]
The rep present in the case was contacted for further investigation of details pertaining to the complaint. It was reported that during the drilling insertion of the side-delivery accuport cannula, the surgeon attempted to redirect the cannula to a different trajectory. It was observed that an extreme amount of bending was forced on the cannula and that immediately following the drilling the cannula fractured at dear the tip in the bone. It was reported that the surgeon was warned during the procedure no to bend the cannula but he underestimated the bending force being created during the attempt to redirect the cannula and broke the cannula into the bone. The broken fragment was left in the bone. Another end-delivery cannula was used to inject the material and complete the procedure. Since there are no x-ray images and there was no product returned, the exact nature of the product failure is unable to be determined.
Patient Sequence No: 1, Text Type: N, H10
[57320544]
Cannula broke during procedure and remained in the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008812173-2016-00020 |
| MDR Report Key | 6010956 |
| Date Received | 2016-10-07 |
| Date of Report | 2017-10-20 |
| Date of Event | 2016-06-21 |
| Date Mfgr Received | 2016-09-09 |
| Date Added to Maude | 2016-10-07 |
| 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 | ACCUPORT DELIVERY CANNULA |
| Generic Name | CANNULA |
| Product Code | FGY |
| Date Received | 2016-10-07 |
| Model Number | N/A |
| Catalog Number | 514.502 |
| Lot Number | KC01961 |
| ID Number | N/A |
| Device Expiration Date | 2018-07-18 |
| 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 | 2016-10-07 |