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 2019-01-14 for MENISCAL DEPLOYMENT GUN 228143 manufactured by Depuy Mitek Llc Us.

Event Text Entries

[133846857] If additional information should become available, a supplemental medwatch will be submitted accordingly. Udi: (b)(4). The lot number is currently unavailable; therefore, the exp date is unavailable. The complaint device is not being returned, therefore unavailable for a physical evaluation. A review into the depuy synthes mitek complaints system revealed no other complaints for this lot of devices that were 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. This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue. 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. A non-conformance search was performed for this product code 228143, lot 3860947 combination and no non-conformances were identified. 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. 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


[133846858] This is report 1 of 2 for the same event. It was reported by the sales rep that during a meniscal repair, it was observed that the coil got stuck when deploying the 2nd implant of the customer's omnispan meniscal repair system with 12 degree needle. The sales rep reported that the coil went under the 2nd implant, got stuck and did not advance it. The surgeon cut the suture between them and left the 1st implant in the meniscus. The surgeon completed the procedure with another like omnispan meniscal applier and another same like implant right adjacent to the original implant. There were no patient consequences or delays reported. The sales rep reported that the surgeon used two more implants to complete the repair and did not feel that the first implant failing caused the plan to be altered.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1221934-2019-55995
MDR Report Key8245700
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-01-14
Date of Report2016-03-17
Date of Event2016-03-17
Date Mfgr Received2016-03-17
Date Added to Maude2019-01-14
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 ContactKARA DITTY-BOVARD
Manufacturer Street325 PARAMOUNT DRIVE
Manufacturer CityRAYNHAM MA 02767
Manufacturer CountryUS
Manufacturer Postal02767
Manufacturer Phone6013142063
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 Received2019-01-14
Catalog Number228143
Lot NumberUNK
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 2019-01-14

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