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 foreign,health professional report with the FDA on 2019-04-01 for MENISCAL DEPLOYMENT GUN 228143 manufactured by Depuy Mitek Llc Us.

Event Text Entries

[140530755] (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4). The lot number is unknown.
Patient Sequence No: 1, Text Type: N, H10


[140530756] It was reported by the affiliate via email that during an acl procedure the meniscal suture technique is started and it was wanted to pass the first point to the meniscus and when the gun was activated, two stitches were skipped at the same time. The specialists stated that the product was presenting faults and decided to not use it or make suture to the meniscus and suggested that the devices be sent for quality control. The affiliate reported that the procedure was completed successfully without alternation to the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1221934-2019-56729
MDR Report Key8470743
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2019-04-01
Date of Report2019-03-06
Date of Event2019-03-05
Date Mfgr Received2019-04-04
Date Added to Maude2019-04-01
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 ContactKARA DITTY-BOVARD
Manufacturer Street325 PARAMOUNT DRIVE
Manufacturer CityRAYNHAM MA 02767
Manufacturer CountryUS
Manufacturer Postal02767
Manufacturer Phone6103142063
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 Received2019-04-01
Returned To Mfg2019-04-04
Catalog Number228143
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDEPUY MITEK LLC US
Manufacturer Address325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-01

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