PERIOST-ELEV STRAIGHT SHAFT ROUND EDG W/ 399.380

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-06-27 for PERIOST-ELEV STRAIGHT SHAFT ROUND EDG W/ 399.380 manufactured by Synthes Gmbh.

Event Text Entries

[3466596] There was the start of oxidation at the transition from the steel part to the handle. This is 1 of 3 reports for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5


[10859955] Synthes is submitting this report as a result of remediation activities related to fda warning letter dated february 2012. Device(s) listed in this report is (are) used for treatment, not diagnosis. Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr. Device is not distributed in the united states, but is similar to device marketed in the usa. The investigation has shown that it concerns very old instruments, which are more than 10 years old. The handles made from canevasit are partially worn out and the shafts present discolorations. No manufacturing related issues were found and it is concluded that high temperature cycles during repeated sterilization processes have led to this occurrence. The lot number has been provided, a review of the device history record is not yet available.
Patient Sequence No: 1, Text Type: N, H10


[11058172] Synthes is submitting this report as a result of remediation activities related to fda warning letter dated february 2012. Device(s) listed in this report is (are) used for treatment, not diagnosis. Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr. Dhr not available as device is older than 15 years. Correct manufacturing date from 04/18/2012 to 10/01/1992. Placeholder.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number8030965-2013-03703
MDR Report Key3193278
Report Source01,07
Date Received2013-06-27
Date of Report2012-04-18
Date Mfgr Received2013-07-11
Device Manufacturer Date1992-10-01
Date Added to Maude2013-09-19
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 ContactT. MCCARRON
Manufacturer Street1302 WRIGHTS LANE EAST
Manufacturer CityWEST CHESTER PA 19380
Manufacturer CountryUS
Manufacturer Postal19380
Manufacturer Phone8006207025
Manufacturer G1SYNTHES GMBH
Manufacturer StreetEIMATTSTRASSE 3 CH-4436
Manufacturer CityOBERDORF
Manufacturer CountrySZ
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePERIOST-ELEV STRAIGHT SHAFT ROUND EDG W/
Product CodeHTE
Date Received2013-06-27
Catalog Number399.380
Lot Number2022
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSYNTHES GMBH
Manufacturer AddressEIMATTSTRASSE 3 CH-4436 OBERDORF SZ


Patients

Patient NumberTreatmentOutcomeDate
10 2013-06-27

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