UNK - NAIL HEAD ELEM: TFN LAG SCREW

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 2020-03-29 for UNK - NAIL HEAD ELEM: TFN LAG SCREW manufactured by Wrights Lane Synthes Usa Products Llc.

Event Text Entries

[185541420] Product complaint#: (b)(4). This report is for an unknown - nail head elem: tfn lag screw/unknown lot number. Without the specific part number, the udi number and 510k number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number, the device history records review could not be completed as no product was received. Investigation summary: product was not returned. Based on the information available, it has been determined that no corrective and preventive action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. 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


[185541421] It was reported that on an unknown date, the surgeon could not insert the unknown lag screw into the unknown titanium trochanteric fixation nail (tfn) nail. There was a surgical delay. The procedure was successfully completed. The patient outcome was fine. This complaint involves two devices. This report is for one unk - nail head elem: tfn lag screw. This report is 2 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2939274-2020-01577
MDR Report Key9895009
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-29
Date of Report2020-02-29
Date Mfgr Received2020-02-29
Date Added to Maude2020-03-29
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNK - NAIL HEAD ELEM: TFN LAG SCREW
Generic NameROD, FIXATION, INTRAMEDULLARY
Product CodeHSB
Date Received2020-03-29
Catalog NumberUNK - NAIL HEAD ELEM: TFN LAG
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
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 2020-03-29

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