MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2020-02-19 for ACCUPORT N/A 308.032.2 manufactured by Zimmer Knee Creations, Inc..
[182700489]
On (b)(6) 2020, during a subchondroplasty procedure, an accuport cannula was inserted into the medial femoral condyle and medial tibial plateau under fluoroscopic guidance. After injection of the accufill through the cannula, the cannula was left in place for 8 minutes per manufacturer specifications while the implant hardened. As the cannula was being removed from the femur, the tip broke off and was left within the condyle. It was noted that during the setting time, the surgeon moved the leg while the cannula was still inside the patient. No extravasation was noted, and the cannula tip was not intra-articular as confirmed by arthroscope. The surgeon had decided to leave the piece of cannula in the patient. The patient was noted as fine, and the surgery was completed successfully. The event was forwarded to zimmer knee creations on (b)(6) 2020 via medwatch form mrf report number 050351000-2020-01. The product was not returned for evaluation; however, a retained sample from the same lot was available for investigation, and the product was determined to be in accordance with specification. The dhr for the raw material and finished goods lot was reviewed, and no anomalies related to the complaint condition were noted. Per the scp surgical technique guide knee free hand technique, after injection, the scope also allows evaluation for and evacuation of any material that has extravasated into the joint. Note, however, that while the accuport injection cannulas are in place, take care while manipulating the knee during scoping, to avoid bending forces on the cannula that may damage the cannula or surrounding bone. This technique was reviewed with the sales representative.
Patient Sequence No: 1, Text Type: N, H10
[182700490]
Broken tip of cannula remains in patient's bone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008812173-2020-00005 |
| MDR Report Key | 9728691 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-02-19 |
| Date of Report | 2020-02-18 |
| Date of Event | 2020-01-10 |
| Date Facility Aware | 2020-01-10 |
| Report Date | 2020-01-13 |
| Date Reported to FDA | 2020-01-13 |
| Date Reported to Mfgr | 2020-01-22 |
| Date Mfgr Received | 2020-01-22 |
| Device Manufacturer Date | 2019-08-05 |
| Date Added to Maude | 2020-02-19 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | 2020-02-19 |
| Model Number | N/A |
| Catalog Number | 308.032.2 |
| Lot Number | 41317 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 5 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 | 2020-02-19 |