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	11/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Patient identifier and date of birth not available for reporting.Additional product code: hwc.(b)(4).Lot unknown.Device malfunctioned intra-operatively and was 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 an initial mid-foot procedure on (b)(6) 2017 a kirschner wire broke intraoperatively.The wire broke while the surgeon was drilling for a cannulated screw placement in the foot.The wire was embedded in the patient bone and no attempt was made to retrieve the fragments.No surgical delay occurred.The surgeon continued with the procedure.The procedure was completed successfully.Patient was stable postoperatively.Concomitant device reported: drill bit (part number unknown, lot number unknown, quantity 1).This is report 1 of 1 for (b)(4).

• 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: 7145973
• Report Number: 2939274-2017-50419
• Device Sequence Number: 19061977
• Product Code: HTY
• UDI-Device Identifier: 10886982057655
• UDI-Public: (01)10886982057655(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 11/28/2017

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: 11/28/2017
• Initial Report FDA Received Date: 12/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 147