BUTTRESS/COMPRESSION NUT FOR 357.369 357.371

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 2019-03-07 for BUTTRESS/COMPRESSION NUT FOR 357.369 357.371 manufactured by Wrights Lane Synthes Usa Products Llc.

Event Text Entries

[138228489] Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Reporter is a synthes employee. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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


[138228490] It was reported that during post-operative inspection on (b)(6) 2019, the blade guide sleeve and compression nut were discovered to be stuck together. There was no patient involvement. This report is for a buttress/compression nut. This is report 2 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2939274-2019-56866
MDR Report Key8400555
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-03-07
Date of Report2019-04-11
Date of Event2019-01-01
Date Mfgr Received2019-04-11
Date Added to Maude2019-03-07
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 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 NameBUTTRESS/COMPRESSION NUT FOR 357.369
Generic NameTRACTION, APPARATUS, NON-POWERED
Product CodeHST
Date Received2019-03-07
Catalog Number357.371
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
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 2019-03-07

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