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,health report with the FDA on 2018-04-13 for PERIOSTEAL ELEVATOR 6MM CURVED BLADE-STRAIGHT EDGE 399.40 manufactured by Wrights Lane Synthes Usa Products Llc.

Event Text Entries

[105933541] Device used for treatment, not diagnosis. No patient involvement reported. Device is an instrument and is not implanted/explanted. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. (b)(6). (b)(4). Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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


[105933542] It was reported that during sterile processing, the brown handles of two (2) periosteal elevator 6mm curved blade-straight edges bled into the tray. This did not occur during surgery and there was no patient involvement. This complaint involves two (2) parts. This report is 2 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2939274-2018-51682
MDR Report Key7430201
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2018-04-13
Date of Report2018-03-22
Date Mfgr Received2018-03-22
Date Added to Maude2018-04-13
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 ContactMR. MICHAEL COTE
Manufacturer Street1302 WRIGHTS LANE EAST
Manufacturer CityWEST CHESTER PA 19380
Manufacturer CountryUS
Manufacturer Postal19380
Manufacturer Phone6107195000
Manufacturer G1SYNTHES TUTTLINGEN
Manufacturer StreetUNTER HASSLEN 5
Manufacturer CityTUTTLINGEN 78532
Manufacturer CountrySZ
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 Received2018-04-13
Catalog Number399.40
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
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 2018-04-13

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