PERIOSTEAL ELEVATOR 3MM CURVED BLADE-STRAIGHT EDGE 399.48

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 2017-11-14 for PERIOSTEAL ELEVATOR 3MM CURVED BLADE-STRAIGHT EDGE 399.48 manufactured by Synthes Tuttlingen.

Event Text Entries

[93003440] Patient? S weight is unknown. (b)(4). Lot number unknown. Device is an instrument and is not implanted/explanted. Complainant device is not expected to be returned for manufacturer review/investigation. 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. 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


[93003441] It was reported that during an open reduction internal fixation (orif) of a pilon fracture performed on (b)(6) 2017, two periosteal elevators broke in half during reduction of fracture fragments. The event did no effect the outcome of the case or cause any significant delay. The time of delay in unknown and patient? S outcome is unknown. This report is for one (1) periosteal elevator 3mm curved blade-straight edge this is report 2 of 2 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9680938-2017-10141
MDR Report Key7030658
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2017-11-14
Date of Report2017-10-21
Date of Event2017-10-21
Date Mfgr Received2017-10-21
Date Added to Maude2017-11-14
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 ContactMICHAEL 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 CountryGM
Manufacturer Postal Code78532
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePERIOSTEAL ELEVATOR 3MM CURVED BLADE-STRAIGHT EDGE
Generic NameELEVATOR
Product CodeHTE
Date Received2017-11-14
Catalog Number399.48
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSYNTHES TUTTLINGEN
Manufacturer AddressUNTER HASSLEN 5 TUTTLINGEN 78532 GM 78532


Patients

Patient NumberTreatmentOutcomeDate
10 2017-11-14

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