MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.2MM GUIDE WIRE 290MM; NAIL,FIXATION,BONE

Model Number	03.010.115
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient¿s information is unknown.Date of event is unknown.(b)(4).Device is an instrument and is not implanted/explanted.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.
Event or Problem Description
It was reported during a retrograde/antegrade femoral nail (rafn) procedure on an unknown date, the drill guide was worn out and the drill bit was starting to stick when passing through it.The surgeon did complain about it not passing through smoothly as it should.There was no harm to the patient and no surgical time delay.Procedure was completed successfully as anticipated.Concomitant device reported: cannulated drill bit (part# 351.27, lot# unknown, qty 1).This report is for one (1) 3.2mm guide wire 290mm.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 3.2MM GUIDE WIRE 290MM
• Common Device Name: NAIL,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7560709
• Report Number: 2939274-2018-52374
• Device Sequence Number: 1317610
• Product Code: JDS
• UDI-Device Identifier: 10886982067869
• UDI-Public: (01)10886982067869
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K970097
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.010.115
• Device Catalogue Number: 03.010.115
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/04/2018
• Initial Report FDA Received Date: 06/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 26 YR