ARTHREX? AR-13995N

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-11 for ARTHREX? AR-13995N manufactured by Arthrex, Inc..

Event Text Entries

[178568030] Metal tip of arthrex scorpion multifire needle broke off in shoulder during a surgical arthroscopy procedure. Xray taken and tip noted to still be in shoulder. Surgeon did not try to remove needle.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9693309
MDR Report Key9693309
Date Received2020-02-11
Date of Report2020-01-27
Date of Event2019-07-22
Report Date2020-01-27
Date Reported to FDA2020-01-27
Date Reported to Mfgr2020-02-11
Date Added to Maude2020-02-11
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameARTHREX?
Generic NameINSTRUMENT, MANUAL, SURGICAL, GENERAL USE
Product CodeMDM
Date Received2020-02-11
Model NumberAR-13995N
Catalog NumberAR-13995N
Lot Number10291516
Device Availability*
Device Age1 DA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerARTHREX, INC.
Manufacturer Address1370 CREEKSIDE BLVD NAPLES FL 34108 US 34108


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-11

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