MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-04-05 for 11G ACCUPORT SIDE 120MM N/A 307.032 manufactured by Zimmer Knee Creations, Inc..
[141113569]
This event was reported in (b)(6). It was discovered on follow up x-ray that the accuport cannula had fractured intraoperatively and approximately 26 mm of the tip of the accuport is retained in the patient. Report from the in-country sales team is that the knee was manipulated while the accuport was in the body. The team reported that the accuport was not redirected during insertion. This was an x-ray finding as the patient is asymptomatic (no side effects were detected). This failure mode, as described above, is related to a bending moment being applied intraoperatively. Per the subchondroplasty scp knee surgical technique, care must be taken to avoid applying bending forces on the cannula while manipulating the knee during scoping, to avoid damage to the cannula or surrounding bone. " the dhr for the finished goods lot was reviewed, and no anomalies related to the complaint condition were noted. The product was not returned for the investigation, as it was discarded. The dhr for the raw material has been requested. Once received, an additional report will be submitted with the findings.
Patient Sequence No: 1, Text Type: N, H10
[141113570]
Piece of cannula left in patient's joint postoperatively.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008812173-2019-00017 |
| MDR Report Key | 8489206 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-05 |
| Date of Report | 2019-04-30 |
| Date of Event | 2019-01-31 |
| Date Mfgr Received | 2019-03-14 |
| Device Manufacturer Date | 2017-10-31 |
| Date Added to Maude | 2019-04-05 |
| 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 | 11G ACCUPORT SIDE 120MM |
| Generic Name | CANNULA |
| Product Code | FGY |
| Date Received | 2019-04-05 |
| Model Number | N/A |
| Catalog Number | 307.032 |
| Lot Number | 38224 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 18 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 | 1. Other | 2019-04-05 |