MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-01-14 for ACCUPORT N/A 307.034 manufactured by Zimmer Knee Creations, Inc..
[174956169]
On (b)(6) 2019, a patient underwent an initial subchondroplasty procedure. Intraoperatively, when the doctor was drilling into the patient's bone with the accuport, the surgeon wanted to change the trajectory of the cannula, so the surgeon backed it out halfway while it was still in the bone and the instrument fractured. The cannula was extracted from the patient, and there were no foreign bodies remaining inside the patient. It is unknown how the cannula was removed. The sales representative attending the case stated that the instrument worked as it should, despite the surgeon error. There were no images provided. It was reported that the patient was fine. The product was not returned for the investigation. Once additional information becomes available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[174956170]
Broken 307. 034 during surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008812173-2020-00004 |
| MDR Report Key | 9587665 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-01-14 |
| Date of Report | 2020-01-28 |
| Date of Event | 2019-12-31 |
| Date Facility Aware | 2019-12-31 |
| Date Mfgr Received | 2019-12-31 |
| Device Manufacturer Date | 2017-05-25 |
| Date Added to Maude | 2020-01-14 |
| 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 | MR. LEO MUNAR |
| Manufacturer Street | 841 SPRINGDALE DRIVE |
| Manufacturer City | EXTON PA 19341 |
| Manufacturer Country | US |
| Manufacturer Postal | 19341 |
| Manufacturer Phone | 4848794553 |
| 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 | 2020-01-14 |
| Model Number | N/A |
| Catalog Number | 307.034 |
| Lot Number | 36898 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 31 MO |
| 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 | 2020-01-14 |