SP2 FEM BOX TRIAL SCREW DRIVER 96-6295 966295

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-26 for SP2 FEM BOX TRIAL SCREW DRIVER 96-6295 966295 manufactured by Depuy Orthopaedics Inc Us.

Event Text Entries

[185148403] Product complaint #: (b)(4). 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


[185148404] It was reported that the screwdriver tip was stripped. No surgical delay.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1818910-2020-09370
MDR Report Key9884642
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-26
Date of Report2020-03-13
Date of Event2020-03-13
Date Mfgr Received2020-03-13
Device Manufacturer Date2004-01-15
Date Added to Maude2020-03-26
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 ContactMS. KARA DITTY-BOVARD
Manufacturer Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 465810988
Manufacturer CountryUS
Manufacturer Postal465810988
Manufacturer Phone6107428552
Manufacturer G1DEPUY ORTHOPAEDICS INC US
Manufacturer Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 465810988
Manufacturer CountryUS
Manufacturer Postal Code465810988
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSP2 FEM BOX TRIAL SCREW DRIVER
Generic NameKNEE INSTRUMENT : SCREWDRIVERS
Product CodeHXX
Date Received2020-03-26
Model Number96-6295
Catalog Number966295
Lot NumberCM0104
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDEPUY ORTHOPAEDICS INC US
Manufacturer Address700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-26

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