ARTHRO KNOT MANIP FULL *EA 214615

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 2019-01-10 for ARTHRO KNOT MANIP FULL *EA 214615 manufactured by Depuy Mitek Llc Us.

Event Text Entries

[132840361] If additional information should become available, a supplemental medwatch will be submitted accordingly. Udi: (b)(4) - incomplete. The lot number is currently unavailable. The complaint device is not being returned, therefore is 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. 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. 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


[132840362] This is report 3 of 3 for the same event. It was reported by the sales rep that during an unspecified surgical procedure of the shoulder, it was observed that the customer's healix awl broke mid-shaft when prepping the bone tunnel while in use with two knot manipulators full loop devices that were cutting suture. The sales rep confirmed that nothing broke or fell inside the patient's joint space. The surgeon completed the procedure with another like devices with no patient consequences. There was a nine minute delay reported to complete the procedure. The sales rep reported that the customer did use fiberwire. The sales rep could not provide the lot numbers for the devices but reported that they were all over four years old and had been heavily used. 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 Number1221934-2018-51622
MDR Report Key8237490
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-01-10
Date of Report2016-03-21
Date of Event2016-03-21
Date Mfgr Received2016-03-21
Date Added to Maude2019-01-10
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 NameARTHRO KNOT MANIP FULL *EA
Generic NameARTHROSCOPIC SUTURING DEVICE
Product CodeHCF
Date Received2019-01-10
Catalog Number214615
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 2019-01-10

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