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 2018-04-04 for ACCUPORT N/A UNK manufactured by Zimmer Knee Creations, Inc..
[104681484]
It was reported a cannula had broken during surgery due to rough handling by the surgeon, per the sales representative who attended the case. There was no reported incident of patient harm. Per the accuport ifu,? Do not bend or exert unnecessary force on cannula during insertion to avoid damaged or broken cannula. "
Patient Sequence No: 1, Text Type: N, H10
[104681485]
Eleven gage cannula broke.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008812173-2018-00013 |
| MDR Report Key | 7397407 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-04-04 |
| Date of Report | 2018-04-04 |
| Date Mfgr Received | 2018-03-23 |
| Date Added to Maude | 2018-04-04 |
| 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 | 2018-04-04 |
| Model Number | N/A |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2018-04-04 |