MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.6MM KIRSCHNER WIRE W/TROCAR POINT 150MM; WIRE,SURGICAL

Model Number	292.16
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional device product code: hty.Device malfunctione intra-operative.Device was not implanted/explanted.Device is not expected to be returned for manufacturer review/investigation.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.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 that on (b)(6) 2018, patient underwent a procedure an open reduction internal fixation of a fracture in both forearms.During the procedure, a 1.6mm k wire broke.It was further explained that the surgeon placed a 3.5 locking compression plate using an unknown locking guide and wire guide.He then attached the 1.6mm k wire as a temporary fixation and as he pulled the guide wire to remove it from the plate the wire more than likely became fatigued and broke during removal.The surgeon over drilled using a cannulated drill bit and he could easily remove the broken piece of the guide wire.No additional medical intervention was required, no unanticipated x-rays were required and there was no harm to the patient.The procedure was completed without any surgical delays.The patient was reported to be stable at the end of the procedure.Concomitant devices reported: 3.5 locking compression plate (part# unknown, lot# unknown, quantity 1) this report is for one (1) 1.6mm kirschner wire w/trocar point 150mm.This is report 1 of 1 for (b)(4).

• Brand Name: 1.6MM KIRSCHNER WIRE W/TROCAR POINT 150MM
• Common Device Name: WIRE,SURGICAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7309606
• Report Number: 2939274-2018-50823
• Device Sequence Number: 13765551
• Product Code: LRN
• UDI-Device Identifier: 20886982180374
• UDI-Public: (01)20886982180374(10)LOT#UNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/31/2018

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: 292.16
• Device Catalogue Number: 292.16
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/31/2018
• Initial Report FDA Received Date: 03/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR