PERIOSTEAL ELEVATOR 6MM CURVED BLADE-STRAIGHT EDGE 399.40

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 2019-01-16 for PERIOSTEAL ELEVATOR 6MM CURVED BLADE-STRAIGHT EDGE 399.40 manufactured by Wrights Lane Synthes Usa Products Llc.

Event Text Entries

[133334120] Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Reporter is synthes sales consultant. 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


[133334121] Device report from synthes reports an event in canada as follows: it was reported that on an unknown date, one (1) chisel blade w/ 10, one (1) chisel blade w/ 16 and one (1) periosteal elevator 6mm curved blade - straight edge were marked as broken in medical device reprocessing department (mdrd). The tip of the two (2) chisel blades were uneven and dull. The tip of the periosteal elevator was dinged and dull. There was no patient and procedure involvement. This report is for one (1) periosteal elevator 6mm. This is report 3 of 3 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2939274-2019-55902
MDR Report Key8255021
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-01-16
Date of Report2018-12-27
Date Mfgr Received2019-01-21
Date Added to Maude2019-01-16
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 G1SYNTHES TUTTLINGEN
Manufacturer StreetUNTER HASSLEN 5
Manufacturer CityTUTTLINGEN 78532
Manufacturer CountryGM
Manufacturer Postal Code78532
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePERIOSTEAL ELEVATOR 6MM CURVED BLADE-STRAIGHT EDGE
Generic NameELEVATOR
Product CodeHTE
Date Received2019-01-16
Returned To Mfg2019-01-21
Model Number399.40
Catalog Number399.40
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 2019-01-16

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