SHAFT FOR 90? SCREWDRIVER 03.505.003

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 2018-12-18 for SHAFT FOR 90? SCREWDRIVER 03.505.003 manufactured by Wrights Lane Synthes Usa Products Llc.

Event Text Entries

[130769998] If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Additional product codes: dzj, hxx. The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. The investigation could not be completed; no conclusion could be drawn at the time of filing this report. A review of the device history records has been requested. Device was used for treatment, not diagnosis.
Patient Sequence No: 1, Text Type: N, H10


[130769999] It was reported that on an unknown date, during an unknown procedure, the 90 degree driver would not lock in screw and kept spinning. It is unknown if there was any surgical delay. There was no patient consequence. This complaint involves one (1) device. This report is 2 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2939274-2018-55453
MDR Report Key8176581
Report SourceCOMPANY REPRESENTATIVE
Date Received2018-12-18
Date of Report2018-11-27
Date Mfgr Received2019-01-24
Device Manufacturer Date2016-04-26
Date Added to Maude2018-12-18
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 FDA3
Event Location3
Manufacturer ContactKARA DITTY-BOVARD
Manufacturer Street1302 WRIGHTS LANE EAST
Manufacturer CityWEST CHESTER PA 19380
Manufacturer CountryUS
Manufacturer Postal19380
Manufacturer Phone6103142063
Manufacturer G1SYNTHES SELZACH
Manufacturer StreetBOHACKERWEG 5
Manufacturer CitySELZACH CO 2545
Manufacturer CountrySZ
Manufacturer Postal Code2545
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSHAFT FOR 90? SCREWDRIVER
Generic NameDRILL, BONE, POWERED
Product CodeDZI
Date Received2018-12-18
Returned To Mfg2018-12-17
Model Number03.505.003
Catalog Number03.505.003
Lot Number8152686
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
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 2018-12-18

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