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,health report with the FDA on 2018-10-11 for MENISCAL DEPLOYMENT GUN 228143 manufactured by Depuy Mitek.

Event Text Entries

[123382650] 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 is unavailable for a physical evaluation. A batch record review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint. Our results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem. Further, a review into the depuy mitek complaints system revealed no other complaints of any kind for this lot that was released to distribution. 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. (b)(4). This report is being filed from the remetrex 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


[123382651] This is report 3 of 5 for the same event. It was reported by the sales rep that during a knee repair surgical procedure, it was observed that two of his omnispan meniscal appliers and three omnispan meniscal repair system, w/ 12 degree needle would not deploy. According to the report, the sales rep reported the grey trigger would not depress, after attempting to force the trigger the first implant shot off the needle. It was reported that the surgeon then replaced the applier and needle; and again, the grey trigger would not depress. It was reported that the surgeon removed the needle, placed a new third needle on the second applier to the same result that the grey trigger would not depress. It was reported that the surgeon completed the procedure with a competitor? S device with no patient consequences or delay. There was patient involvement reported. There were no injuries, medical intervention or prolonged hospitalization. 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 Number1221934-2018-54923
MDR Report Key7955890
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2018-10-11
Date of Report2014-09-24
Date of Event2014-09-24
Date Mfgr Received2014-09-24
Device Manufacturer Date2014-06-16
Date Added to Maude2018-10-11
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
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 Received2018-10-11
Catalog Number228143
Lot Number3781272
Device Expiration Date2017-03-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDEPUY MITEK
Manufacturer Address325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767


Patients

Patient NumberTreatmentOutcomeDate
10 2018-10-11

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.