MENISCAL DEPLOYMENT GUN 228143

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 2018-09-18 for MENISCAL DEPLOYMENT GUN 228143 manufactured by Depuy Mitek Llc Us.

Event Text Entries

[120562604] If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Evaluation statement: the complaint device is not being returned, therefore unavailable for a physical evaluation. Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system. Therefore, we cannot determine what caused the user to experience the reported event, we cannot discern a root cause for the reported failure mode. At this point in time, no corrective action is required and no further action is warranted. However, depuy 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. This report is being filed from the etq complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Patient Sequence No: 1, Text Type: N, H10


[120562605] It was reported during a meniscal refixation the applicator would not release. A like product was used to complete procedure. Please see also medwatch reports: 1221934-2018-54674, 1221934-2018-54671, 1221934-2018-54672.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1221934-2018-54673
MDR Report Key7885176
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-09-18
Date of Report2015-10-15
Date of Event2015-10-07
Date Mfgr Received2015-10-15
Date Added to Maude2018-09-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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
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 NameMENISCAL DEPLOYMENT GUN
Generic NameORTHOPAEDIC CERCLAGE APPLIER
Product CodeGEF
Date Received2018-09-18
Catalog Number228143
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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 2018-09-18

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