TORQUE LIMITING HANDLE/QUICK RELEASE-6MM HEX COUPLING 321.133

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-20 for TORQUE LIMITING HANDLE/QUICK RELEASE-6MM HEX COUPLING 321.133 manufactured by Wrights Lane Synthes Usa Products Llc.

Event Text Entries

[186760459] Reporter is j&j employee. The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10


[186760460] It was reported on february 24, 2020, during evaluation at service and repair it was found out that the torque limiting handle qiuick release coupling had failed in calibration. There was no patient involvement. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2939274-2020-01448
MDR Report Key9862894
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-20
Date of Report2020-02-24
Date Mfgr Received2020-03-24
Device Manufacturer Date2012-08-31
Date Added to Maude2020-03-20
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 Street1302 WRIGHTS LANE EAST
Manufacturer CityWEST CHESTER PA 19380
Manufacturer CountryUS
Manufacturer Postal19380
Manufacturer Phone6103142063
Manufacturer G1MONUMENT
Manufacturer Street1101 SYNTHES AVENUE
Manufacturer CityMONUMENT CO 80132
Manufacturer CountryUS
Manufacturer Postal Code80132
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTORQUE LIMITING HANDLE/QUICK RELEASE-6MM HEX COUPLING
Generic NameSCREWDRIVERS
Product CodeHXX
Date Received2020-03-20
Returned To Mfg2020-02-25
Model Number321.133
Catalog Number321.133
Lot Number6972670-26
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerWRIGHTS LANE SYNTHES USA PRODUCTS LLC
Manufacturer Address1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-20

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