CANNULATED 2.5MM HEXAGONAL SCREWDRIVER 314.29

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-23 for CANNULATED 2.5MM HEXAGONAL SCREWDRIVER 314.29 manufactured by Wrights Lane Synthes Usa Products Llc.

Event Text Entries

[186754319] Initial reporter is synthes sales representative. The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. 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


[186754320] It was reported that on an unknown date during an unknown procedure, the cannulated hexagonal screwdriver was broken. The procedure was completed without surgical delay. There was no patient consequence reported. This complaint involves one (1) device. This report is for one (1) cannulated 2. 5mm hexagonal screwdriver. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2939274-2020-01455
MDR Report Key9865578
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-23
Date of Report2020-02-25
Date Mfgr Received2020-02-25
Date Added to Maude2020-03-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKARA DITTY-BOVARD
Manufacturer Street1302 WRIGHTS LANE EAST
Manufacturer CityWEST CHESTER PA 19380
Manufacturer CountryUS
Manufacturer Postal19380
Manufacturer Phone6103142063
Manufacturer G1BRANDYWINE
Manufacturer Street1303 GOSHEN PARKWAY
Manufacturer CityWEST CHESTER PA 19380
Manufacturer CountryUS
Manufacturer Postal Code19380
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCANNULATED 2.5MM HEXAGONAL SCREWDRIVER
Generic NameSCREWDRIVER
Product CodeHXX
Date Received2020-03-23
Returned To Mfg2020-03-11
Model Number314.29
Catalog Number314.29
Lot NumberA4CC389
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerWRIGHTS LANE SYNTHES USA PRODUCTS LLC
Manufacturer Address1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-23

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