MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-05-01 for ARTHREX ANGEL SYSTEM WITH ASPIRATION KIT ANGEL SYSTEM WITH ASPIRATION KIT W/ ACDA ABS-10062T manufactured by Arthrex, Inc..
[143669073]
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation. The device was reported to have been discarded. The root cause of the event could not be determined from the information available and without device evaluation.
Patient Sequence No: 1, Text Type: N, H10
[143669074]
It was reported by the sales rep that during a rotator cuff repair the surgeon aspirated marrow and passed off the field for processing. When the bmc was separating into the syringe it continued to push product into the syringe until the plunger pushed off, losing all of the product onto the floor. The case was completed without using the bmc.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220246-2019-01068 |
| MDR Report Key | 8568458 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-05-01 |
| Date of Report | 2019-11-07 |
| Date of Event | 2019-04-02 |
| Date Mfgr Received | 2019-04-11 |
| Device Manufacturer Date | 2018-11-26 |
| Date Added to Maude | 2019-05-01 |
| 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 | VIK BAJNATH |
| Manufacturer Phone | 8009337001 |
| Manufacturer G1 | ARTHREX, INC. |
| Manufacturer Street | 1370 CREEKSIDE BOULEVARD |
| Manufacturer City | NAPLES FL 341081945 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 341081945 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARTHREX ANGEL SYSTEM WITH ASPIRATION KIT |
| Generic Name | PLATELET AND PLASMA SEPARATOR FOR BONE GRAFT HANDLING |
| Product Code | ORG |
| Date Received | 2019-05-01 |
| Model Number | ANGEL SYSTEM WITH ASPIRATION KIT W/ ACDA |
| Catalog Number | ABS-10062T |
| Lot Number | 831788025 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHREX, INC. |
| Manufacturer Address | 1370 CREEKSIDE BOULEVARD NAPLES FL 341081945 US 341081945 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-01 |