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 2018-04-26 for ACCUPORT N/A 307.032 manufactured by Zimmer Knee Creations, Inc..
[106698390]
After the surgery, it was found on the post operative films that a small portion of the distal end of the cannula has been retained in the patients femur. The surgeon determined that it would be more harmful to try and remove the than to leave. A supplement report will be submitted with additional information from the investigation.
Patient Sequence No: 1, Text Type: N, H10
[106698411]
Scp cannula broke off in the patients femur.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008812173-2018-00017 |
| MDR Report Key | 7466437 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-04-26 |
| Date of Report | 2018-05-01 |
| Date of Event | 2018-04-05 |
| Date Mfgr Received | 2018-04-05 |
| Date Added to Maude | 2018-04-26 |
| 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 | 2018-04-26 |
| Model Number | N/A |
| Catalog Number | 307.032 |
| Lot Number | 36888 |
| 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 | 2018-04-26 |