2.0MM THREADED DRILL GUIDE 323.061

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 2007-05-17 for 2.0MM THREADED DRILL GUIDE 323.061 manufactured by Synthes (usa).

Event Text Entries

[15557904] Drill guide color indicator ring is purple instead of orange.
Patient Sequence No: 1, Text Type: D, B5


[15919148] Subject device is an instrument and is not implanted. Incorrect color coding was discovered during inventory stocking and was never used in surgery. Review of device history records shows that the part was mfg according to an incorrect design index. Investigations have shown that the complained threaded drill guides are marked purple instead of orange.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1719045-2007-00033
MDR Report Key851720
Report Source05,07
Date Received2007-05-17
Date of Report2007-01-03
Date of Event2007-01-02
Date Mfgr Received2007-01-02
Device Manufacturer Date2006-10-07
Date Added to Maude2007-05-24
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 Street1302 WRIGHTS LANE EAST
Manufacturer CityWEST CHESTER PA 19380
Manufacturer CountryUS
Manufacturer Postal19380
Manufacturer Phone8006207025
Manufacturer G1SYNTHES (USA)
Manufacturer Street1051 MONUMENT AVE.
Manufacturer CityMONUMENT CO 80132
Manufacturer CountryUS
Manufacturer Postal Code80132
Single Use3
Remedial ActionRC
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name2.0MM THREADED DRILL GUIDE
Generic NameTHREADED DRILL GUIDE
Product CodeLXI
Date Received2007-05-17
Returned To Mfg2007-02-02
Model NumberNA
Catalog Number323.061
Lot Number1531434
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key839084
ManufacturerSYNTHES (USA)
Manufacturer AddressWEST CHESTER PA 19380 US


Patients

Patient NumberTreatmentOutcomeDate
10 2007-05-17

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