ARTHRO SUTURE SCISSORS *EA 214605

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 2019-01-24 for ARTHRO SUTURE SCISSORS *EA 214605 manufactured by Depuy Mitek Llc Us.

Event Text Entries

[133952007] If additional information should become available, a supplemental medwatch will be submitted accordingly. (b)(4). The lot number is currently unavailable. The complaint device is not being returned; it was discarded by the customer and therefore is unavailable for a physical evaluation. Furthermore, no lot numbers were supplied which precludes conducting a device history record 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 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. 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.
Patient Sequence No: 1, Text Type: N, H10


[133952008] It was reported by the sales rep that the customer's suture scissors broke during a shoulder arthroscopy procedure. According to the reporter, the scissors did not break in the patient. The case was completed with another like device. The lot was unknown but the rep stated they appear to have heavy use, unaware of how old they are. The sales rep was not present but reported no adverse 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 Number1221934-2018-53428
MDR Report Key8273436
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-01-24
Date of Report2017-03-10
Date of Event2017-03-10
Date Mfgr Received2017-03-10
Date Added to Maude2019-01-24
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 SUTURE SCISSORS *EA
Generic NameSUTURE CUTTER
Product CodeFZT
Date Received2019-01-24
Catalog Number214605
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 2019-01-24

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