MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-02-21 for ACCUPORT N/A 307.032 manufactured by Zimmer Knee Creations, Inc..
[100577545]
During the surgery, the accuport was manipulated by surgeon while the cannula and stylet were in the body, and the cannula and stylet broke inside the patient's body. The tip of the cannula and stylet remain in the patient. Per the instructions for use,? Use proper technique to remove cannula from bone to avoid damaged or broken cannula. Fully insert stylus into cannula, then remove stylus and cannula with surgical drill in reverse.?
Patient Sequence No: 1, Text Type: N, H10
[100577546]
Broken tip of cannula inside patients femur during scp.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008812173-2018-00006 |
| MDR Report Key | 7286106 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-02-21 |
| Date of Report | 2018-03-09 |
| Date of Event | 2018-02-06 |
| Date Mfgr Received | 2018-02-06 |
| Date Added to Maude | 2018-02-21 |
| 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 | 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 | 3 |
| Brand Name | ACCUPORT |
| Generic Name | CANNULA |
| Product Code | FGY |
| Date Received | 2018-02-21 |
| Model Number | N/A |
| Catalog Number | 307.032 |
| Lot Number | 26888 |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2018-02-21 |