PERIOSTEAL ELEVATOR 3MM CURVED BLADE - ROUND EDGE 399.481

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 2018-08-15 for PERIOSTEAL ELEVATOR 3MM CURVED BLADE - ROUND EDGE 399.481 manufactured by Wrights Lane Synthes Usa Products Llc.

Event Text Entries

[117151573] There was no known reported patient involvement associated with the complained event. Device is an instrument and is not implanted/explanted. The subject device has been received and the product evaluation is in progress. No conclusion can be drawn. A review of the device history records has been requested and is currently pending completion. 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


[117151574] It was reported that on (b)(6) 2018, the central processing manager presented one (1) periosteal elevator curved blade-round edge, one (1) periosteal elevator curved blade-straight edge, one (1) cruciform screwdriver, and one (1) reduction forceps with points ratchet that were cracked or broken. It was unknown when the devices became damaged. There was no patient involvement. This report is for one (1) periosteal elevator 3mm curved blade - round edge. This is report 1 of 4 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2939274-2018-53332
MDR Report Key7784452
Report SourceCOMPANY REPRESENTATIVE
Date Received2018-08-15
Date of Report2018-07-31
Date Mfgr Received2018-09-21
Device Manufacturer Date2004-06-29
Date Added to Maude2018-08-15
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 WRIGHT LANE EAST
Manufacturer CityWEST CHESTER PA 19380
Manufacturer CountryUS
Manufacturer Postal19380
Manufacturer Phone6107195000
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 3MM CURVED BLADE - ROUND EDGE
Generic NameELEVATOR
Product CodeHTE
Date Received2018-08-15
Returned To Mfg2018-08-14
Model Number399.481
Catalog Number399.481
Lot NumberA7NA24
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 2018-08-15

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