4.75 HEALIX ADVANCE KNTLSS BR 222330

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2020-03-18 for 4.75 HEALIX ADVANCE KNTLSS BR 222330 manufactured by Depuy Mitek Llc Us.

Event Text Entries

[188655600] Product complaint # (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Udi: (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[188655601] It was reported by the affiliate that during an arthroscopic rotator cuff repair the tip of the 4. 75 healix advance kntlss br broke off during the insertion. The procedure was completed using a replacement, however the surgeon had to create a new burr hole. No fragments were left in the patient's body. No surgical delay was reported. No additional information was provided. Additional information provided by the affiliate reported the device will not be returning for evaluation.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1221934-2020-00906
MDR Report Key9850282
Report SourceFOREIGN
Date Received2020-03-18
Date of Report2020-03-05
Date of Event2020-03-03
Date Mfgr Received2020-03-31
Date Added to Maude2020-03-18
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 G1MEDOS INT MITEK
Manufacturer StreetCHEMIN BLANC 38
Manufacturer CityLE LOCLE 02400
Manufacturer CountrySZ
Manufacturer Postal Code02400
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name4.75 HEALIX ADVANCE KNTLSS BR
Generic NameSOFT-TISSUE ANCHOR, BIOABSORBABLE
Product CodeMAI
Date Received2020-03-18
Model Number222330
Catalog Number222330
Lot Number3L68946
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
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 2020-03-18

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