MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-08-03 for 8G ACCUPORT SIDE 200MM N/A 308.082 manufactured by Zimmer Knee Creations, Inc..
[115935626]
During a conversation with the surgeon, it was communicated that the surgeon attempted to redirect his trajectory during the drilling of the accuport into the patient. The tip of the cannula broke off and remained in the patient; the surgeon did not attempt to retrieve the broken fragment. A new accuport was utilized and the procedure progressed without incident. Per the accuport ifu,? Do not bend or exert unnecessary force on cannula during insertion to avoid damaged or broken cannula. Do not attempt to redirect cannula while in bone. Remove the cannula from the bone and redirect to the desired trajectory through the same opening. "
Patient Sequence No: 1, Text Type: N, H10
[115935627]
Cannula breakage; tip of cannula retained in patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008812173-2018-00030 |
| MDR Report Key | 7747309 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-08-03 |
| Date of Report | 2018-09-07 |
| Date of Event | 2018-06-20 |
| Date Facility Aware | 2018-07-18 |
| Report Date | 2018-07-18 |
| Date Reported to Mfgr | 2018-07-18 |
| Date Mfgr Received | 2018-07-18 |
| Date Added to Maude | 2018-08-03 |
| 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 | 8G ACCUPORT SIDE 200MM |
| Generic Name | CANNULA |
| Product Code | FGY |
| Date Received | 2018-08-03 |
| Model Number | N/A |
| Catalog Number | 308.082 |
| Lot Number | 38805 |
| 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 | 2018-08-03 |