PERIOSTEAL ELEVATOR, STRAIGHT SHAFT ROUND EDGE 399.370

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2013-12-26 for PERIOSTEAL ELEVATOR, STRAIGHT SHAFT ROUND EDGE 399.370 manufactured by Synthes Usa.

Event Text Entries

[4123701] Device report from synthes (b)(4) reports an event from (b)(6) as follows: it was reported that a chisel was used in an implant removal procedure. The chisel broke during removal of a callus. The case involved a fractured tibia 1/2 shaft distal. This is report 2 of 2 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5


[11452636] Device is an instrument and is not implanted/explanted. (b)(6). Subject device has been received and is currently in the evaluation process. Investigation is ongoing; no conclusion could be drawn. It is noted there is incomplete information on this form; this event is being investigated. If information is obtained that was not available for the initial medwatch, a follow-up will be filed as appropriate. Placeholder.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2520274-2013-07793
MDR Report Key3538315
Report Source01,05,07
Date Received2013-12-26
Date of Report2013-11-27
Date of Event2013-10-16
Device Manufacturer Date2013-02-27
Date Added to Maude2014-04-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMARY HABER
Manufacturer Street1302 WRIGHTS LANE EAST
Manufacturer CityWEST CHESTER PA 19380
Manufacturer CountryUS
Manufacturer Postal19380
Manufacturer Phone8006207025
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePERIOSTEAL ELEVATOR, STRAIGHT SHAFT ROUND EDGE
Product CodeHTE
Date Received2013-12-26
Returned To Mfg2013-12-23
Catalog Number399.370
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSYNTHES USA
Manufacturer AddressWEST CHESTER PA


Patients

Patient NumberTreatmentOutcomeDate
10 2013-12-26

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