IDEAL SUTURE SHUTTLE 45 DEGREES LEFT 251003

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-01-28 for IDEAL SUTURE SHUTTLE 45 DEGREES LEFT 251003 manufactured by Depuy Mitek Llc Us.

Event Text Entries

[135427817] If additional information should become available, a supplemental medwatch will be submitted accordingly. (b)(4). The complaint device is not being returned, therefore unavailable for a physical evaluation. A review into the depuy 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. A review of the device history record indicated that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed. 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 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 (b)(4) 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


[135427818] This is report 1 of 3 for the same event. It was reported by the affiliate in (b)(6) that during a labral repair surgical procedure, it was observed that the nitinol wire broke when pulling the ideal suture shuttle 45 degrees left tape through. It was reported that this happened on three ideal suture shuttle 45 degrees left devices. According to the reporter, the surgeon was pulling gently but the devices still broke. The surgeon opened three extra shuttles to complete the procedure with a 15 minute 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 Number1221934-2018-53458
MDR Report Key8282233
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-01-28
Date of Report2017-02-14
Date of Event2017-02-14
Date Mfgr Received2019-01-29
Device Manufacturer Date2016-06-01
Date Added to Maude2019-01-28
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 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 NameIDEAL SUTURE SHUTTLE 45 DEGREES LEFT
Generic NameSUTURE/NEEDLE PASSER, SINGLE-USE
Product CodeHCF
Date Received2019-01-28
Catalog Number251003
Lot Number16F14
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 2019-01-28

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