INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM 03.010.473

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 INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM 03.010.473 manufactured by Wrights Lane Synthes Usa Products Llc.

Event Text Entries

[185948510] Reporter is a synthes employee. The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. 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


[185948511] It was reported that on (b)(6) 2020 the tip of the two (2) inter-lock screw drivers were noticed to have bent and twisted. The issue was discovered during the assembling of trays in the central processing department. There were no patient or surgical involvement. Concomitant device: unknown trays (part unknown, lot # unknown, quantity unknown). This report is for one inter-lock screwdriver t25/ 3. 5mm hex/ 224mm. This is report 2 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2939274-2020-01475
MDR Report Key9868097
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 G1WERK H
Manufacturer StreetIM BIFANG 6
Manufacturer CityHAEGENDORF 4614
Manufacturer CountrySZ
Manufacturer Postal Code4614
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM
Generic NameSCREWDRIVERS
Product CodeHXX
Date Received2020-03-23
Returned To Mfg2020-03-17
Model Number03.010.473
Catalog Number03.010.473
Lot Number1L54567
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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