ARTHREX? AR-1317FT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-24 for ARTHREX? AR-1317FT manufactured by Arthrex, Inc..

Event Text Entries

[184709588] During a right middle finger flexor tendon reconstruction with autograft, two anthrex nano suture anchors broke, while securing a tendon. Additional suture anchors were used successfully to fixate the tendon. Implant name: suture anchor, nano corkscrew ft with 3-0 fiberwire suture with two 1/2 circle taper point needles with k-wires.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9871415
MDR Report Key9871415
Date Received2020-03-24
Date of Report2020-03-05
Date of Event2020-02-14
Report Date2020-03-11
Date Reported to FDA2020-03-11
Date Reported to Mfgr2020-03-24
Date Added to Maude2020-03-24
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
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 NameFASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
Product CodeMBI
Date Received2020-03-24
Model NumberAR-1317FT
Catalog NumberAR-1317FT
Lot Number10503127
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
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 2020-03-24

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