ARTHREX ANGEL SYSTEM WITH ASPIRATION KIT ANGEL SYSTEM WITH ASPIRATION KIT W/ ACDA ABS-10062T

MAUDE Adverse Event Report

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..

Event Text Entries

[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


MAUDE Entry Details

Report Number1220246-2019-01068
MDR Report Key8568458
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2019-05-01
Date of Report2019-11-07
Date of Event2019-04-02
Date Mfgr Received2019-04-11
Device Manufacturer Date2018-11-26
Date Added to Maude2019-05-01
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactVIK BAJNATH
Manufacturer Phone8009337001
Manufacturer G1ARTHREX, INC.
Manufacturer Street1370 CREEKSIDE BOULEVARD
Manufacturer CityNAPLES FL 341081945
Manufacturer CountryUS
Manufacturer Postal Code341081945
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameARTHREX ANGEL SYSTEM WITH ASPIRATION KIT
Generic NamePLATELET AND PLASMA SEPARATOR FOR BONE GRAFT HANDLING
Product CodeORG
Date Received2019-05-01
Model NumberANGEL SYSTEM WITH ASPIRATION KIT W/ ACDA
Catalog NumberABS-10062T
Lot Number831788025
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerARTHREX, INC.
Manufacturer Address1370 CREEKSIDE BOULEVARD NAPLES FL 341081945 US 341081945


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-05-01

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