MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC 1.6MM NON-THREADED GUIDE WIRE TROCAR POINT 220MM; PIN, FIXATION, SMOOTH

Model Number	02.226.001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional procode hwc.This report is for a threaded guide wire - unknown lot.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 that during a foot procedure, four (4) wires broke during use.The surgeon was inserting the first 1.6 mm compression wire (03.211.420) with a drill to implant a va (variable angle) midfoot plate, when the proximal portion of the compression wire broke and was easily retrieved with a needle driver.The plate was inserted successfully.A 1.6 mm threaded guide wire (02.226.000) was used to implant one of the 4.5 mm headless compression screws when it broke and was removed with a needle driver and another guide wire was used to complete successful insertion of the screw.Another 1.6 mm compression wire (03.211.420) was used to successfully place a second va (variable angle) midfoot plate and during removal of the compression wire, the wire broke distally.The broken compression wire was easily removed with a needle driver.A 1.6 mm non-threaded guide wire (02.226.001) was used to implant one of the 4.5 mm headless compression screws for the second plate when it broke and was removed with a needle driver and another guide wire was used to complete successful insertion of the screw.There was an approximate five minute surgical delay to retrieve all broken pieces.Routine intraoperative x-rays were taken.The procedure was completed successfully and the patient was reported to be stable.Concomitant devices reported: variable angle midfoot plate (part # unknown, lot # unknown, quantity of 2), 4.5 mm headless compression screw (part # unknown, lot # unknown, quantity of 2), drill (non-synthes) (part # unknown, lot # unknown, quantity of 1) and needle driver (non-synthes) (part # unknown, lot # unknown, quantity of 1).This complaint involves two (2) devices.This report is for a threaded guide wire.This report is 2 of 2 for (b)(4).
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.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.

• Brand Name: 1.6MM NON-THREADED GUIDE WIRE TROCAR POINT 220MM
• Common Device Name: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): WRIGHTS LANE: SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7171647
• Report Number: 2939274-2018-50106
• Device Sequence Number: 918008
• Product Code: HTY
• UDI-Device Identifier: 10886982057655
• UDI-Public: (01)10886982057655(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K080943
• 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,Followup
• Report Date (Section B): 12/11/2017

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: 02.226.001
• Device Catalogue Number: 02.226.001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2017
• Supplement Date Received by Manufacturer: 01/16/2018
• Initial Report FDA Received Date: 01/08/2018
• Supplement Report FDA Received Date: 01/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR