MTATARSAL SURFACE REAMER SZ. 30/40 MSR-890-30/40

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-02-18 for MTATARSAL SURFACE REAMER SZ. 30/40 MSR-890-30/40 manufactured by Ascension Orthopedics.

Event Text Entries

[21803928] This is the first report of two reports concerning the same pt surgery. This report concerns the metatarsal surface reamer sc. 30/40 (msr-890-30/40). It was reported the surgeon used the movement set for a total metatarsal phalangeal joint (mpj) placement. The surgeon had difficulty with the metatarsal reamer 30/40 size and with the phalanx reamer 10/20. The devices seemed dull and they did not ream the bone. Back up reamer was not available. The surgeon used a burr to complete the surgery. The surgery time was extended 45 minutes. There was no injury to the pt alleged.
Patient Sequence No: 1, Text Type: D, B5


[22010326] To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1651501-2014-00009
MDR Report Key3770730
Report Source05,07
Date Received2014-02-18
Date of Report2014-01-24
Date of Event2014-01-24
Date Mfgr Received2014-02-05
Date Added to Maude2014-05-14
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 FDA0
Event Location0
Manufacturer ContactCAREN FINKELSTEIN
Manufacturer Street315 ENTERPRISE DRIVE
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Manufacturer Phone6099362341
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMTATARSAL SURFACE REAMER SZ. 30/40
Generic NameMOVEMENT GREAT TOE INSTRUMENTS
Product CodeKWF
Date Received2014-02-18
Catalog NumberMSR-890-30/40
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerASCENSION ORTHOPEDICS
Manufacturer AddressAUSTIN TX 78754 US 78754


Patients

Patient NumberTreatmentOutcomeDate
10 2014-02-18

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