4.0MM FEMALE HEX DRIVER 2100-70-155 210070155

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 2020-03-23 for 4.0MM FEMALE HEX DRIVER 2100-70-155 210070155 manufactured by Depuy Ireland - 9616671.

Event Text Entries

[184493699] Product complaint # ==> (b)(4). Examination of the returned device confirmed the reported event. The damage is consistent with device use from normal use and servicing and the investigation did not establish a need for corrective action. Examination of the device found that the inside hex driver feature exhibits a crack, wear and stripping. There are cracks in the driver feature walls. There is no breakage or missing material. Depuy synthes considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary. 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


[184493700] It was reported that the 4. 0mm green driver was? Stripped? According to surgeon customer. No surgical delay.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1818910-2020-08860
MDR Report Key9866273
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-23
Date of Report2020-03-04
Date of Event2020-03-04
Date Mfgr Received2020-03-24
Device Manufacturer Date2012-07-09
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 ContactMS. KARA DITTY-BOVARD
Manufacturer Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 465810988
Manufacturer CountryUS
Manufacturer Postal465810988
Manufacturer Phone6107428552
Manufacturer G1DEPUY ORTHOPAEDICS, INC. 1818910
Manufacturer Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 465820988
Manufacturer CountryUS
Manufacturer Postal Code465820988
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name4.0MM FEMALE HEX DRIVER
Generic NameEXTREMITY INSTRUMENTS : SCREWDRIVERS
Product CodeHXX
Date Received2020-03-23
Returned To Mfg2020-03-13
Model Number2100-70-155
Catalog Number210070155
Lot NumberPG217705
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDEPUY IRELAND - 9616671
Manufacturer AddressLOUGHBEG RINGASKIDDY CO. CORK EI


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-23

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