ACL DISPOSABLE KIT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-24 for ACL DISPOSABLE KIT manufactured by Depuy Mitek, Inc..

Event Text Entries

[131765602] During surgery, while putting in a screw implant, a nitinol wire tip broke off inside the patient's knee. The wire was in the middle core of the screw and upon removal, a portion broke off, was able to be removed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5082562
MDR Report Key8196262
Date Received2018-12-24
Date of Report2018-12-21
Date of Event2018-12-10
Date Added to Maude2018-12-26
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameACL DISPOSABLE KIT
Generic NameKIT, SURGICAL INSTRUMENT, DISPOSABLE
Product CodeKDD
Date Received2018-12-24
Lot NumberL973653
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerDEPUY MITEK, INC.


Patients

Patient NumberTreatmentOutcomeDate
10 2018-12-24

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