2.5MM KIRSCHNER WIRE W/TROCAR POINT 285MM 292.26

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-16 for 2.5MM KIRSCHNER WIRE W/TROCAR POINT 285MM 292.26 manufactured by Wrights Lane Synthes Usa Products Llc.

Event Text Entries

[183708396] Additional product code: hty. 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. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. 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


[183708397] It was reported that on (b)(6) 2017, the patient underwent an open reduction and internal fixation of right olecranon nonunion with distal radius autograft, removal of right radial head prosthetic secondary to loosening, revision right radial head arthroplasty and removal of failed tension band construct. The implants removed were synthes radial head prosthetic and tension band wire construct wherein two (2) k-wires were loose. On (b)(6) 2016, after sustaining a fall which resulted in an olecranon and comminuted radial head fracture, the patient underwent an open reduction and internal fixation of olecranon fracture and endo-prosthetic replacement of the proximal radius. The patient was implanted with a synthes radial head and stem. Post-operatively, the patient had improvement but started noting worsening pain and issues with her hardware. On (b)(6) 2016, the patient underwent a partial removal of the exposed hardware from the tension band wiring but was not fully removed since there was no concern for infection. On (b)(6) 2017, during a doctor's visit, the patient continues to report that she is back to doing all of her normal activities without restrictions. She is having only occasional discomfort in cold weather, but this is completely tolerable. This is 2 of 2 for report (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2939274-2020-01286
MDR Report Key9834963
Report SourceOTHER
Date Received2020-03-16
Date of Report2020-02-27
Date of Event2017-02-21
Date Mfgr Received2020-03-06
Date Added to Maude2020-03-16
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 G1ELMIRA
Manufacturer Street35 AIRPORT ROAD
Manufacturer CityHORSEHEADS NY 14845
Manufacturer CountryUS
Manufacturer Postal Code14845
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name2.5MM KIRSCHNER WIRE W/TROCAR POINT 285MM
Generic NameWIRE,SURGICAL
Product CodeLRN
Date Received2020-03-16
Catalog Number292.26
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
101. Required No Informationntervention 2020-03-16

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