CORDCUTTER *EA 214646

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-11-15 for CORDCUTTER *EA 214646 manufactured by Depuy Mitek Llc Us.

Event Text Entries

[127354659] If additional information should become available, a supplemental medwatch will be submitted accordingly. (b)(4)-incomplete. The lot number is currently unavailable. Investigation summary: the complaint device is not being returned, it is retained by the customer, therefore unavailable for a physical evaluation. This complaint cannot be confirmed. ? No further information regarding the technique or instruments used has been provided to determine a root cause for this failure. If any additional information is obtained, this complaint will be re-opened to capture that information. At this point in time, no corrective action is required, and no further action is warranted. ? However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
Patient Sequence No: 1, Text Type: N, H10


[127354660] It was reported by the affiliate in (b)(6) that the stopper on the cordcutter device physically broke. It was not reported if the device was used in surgery, or if there was patient involvement. It was not reported if there were any delays in a surgical procedure or if a spare device was available. It was not reported if there were any injuries, medical intervention or prolonged hospitalization. The exact date of the event was unknown but was noted to have occurred in 2018. All available information has been disclosed. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1221934-2018-55316
MDR Report Key8073916
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-11-15
Date of Report2018-11-09
Date of Event2018-01-01
Date Mfgr Received2018-11-29
Date Added to Maude2018-11-15
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 ContactMRS. JENNIFER LAWRENCE
Manufacturer Street325 PARAMOUNT DRIVE
Manufacturer CityRAYNHAM MA 02767
Manufacturer CountryUS
Manufacturer Postal02767
Manufacturer Phone5088808100
Manufacturer G1DEPUY MITEK LLC US
Manufacturer Street325 PARAMOUNT DRIVE
Manufacturer CityRAYNHAM MA 02767
Manufacturer CountryUS
Manufacturer Postal Code02767
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCORDCUTTER *EA
Generic NameSUTURE CUTTER
Product CodeFZT
Date Received2018-11-15
Catalog Number214646
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDEPUY MITEK LLC US
Manufacturer Address325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767


Patients

Patient NumberTreatmentOutcomeDate
10 2018-11-15

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