MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM / TI CANN FRN / PF 400MM / LEFT - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.033.041S
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Device malfunctioned intra-operatively and was implanted.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was 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.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 the guide pin missed the nail and went anterior during a femoral recon nail procedure on (b)(6) 2018.The surgeon was using the new recon nail.The surgeon checked the nail and jig alignment on the back table with the cannulas and a guide pin.Everything lined up.When the surgeon inserted the nail and first tried to put in the guide pins for the recon screws they went through the nail perfectly.The surgeon had to adjust the pins more anterior so the surgeon rotated the jig posteriorly and when the surgeon reinserted the guide pin, it missed the nail and went anterior.The surgeon had to play around with it for a few minutes and take additional fluoro shots until the surgeon was finally able to get the guide pin through the nail.At the end of the case, the sales consultant and the surgeons discussed that when they tried to rotate the nail anterior or posterior that it correlates with changing the trajectory instead of everything moving in the same plane.There was no patient consequence.No other additional information available.This complaint involves two (2) devices.This report is 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Added concomitant device.Corrected data: event or problem: corrected quantity of involved devices.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
This complaint involves 3 devices.Concomitant device reported: unknown recon screws (part # unknown, lot # unknown, quantity unknown).This report is for one (1) fem recon nail pf ø10 le l400 tan.

• Brand Name: 10MM / TI CANN FRN / PF 400MM / LEFT - STERILE
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7474590
• Report Number: 2939274-2018-51960
• Device Sequence Number: 114120
• Product Code: HSB
• UDI-Device Identifier: 10886982270917
• UDI-Public: (01)10886982270917
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K172157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2018

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: 04.033.041S
• Device Catalogue Number: 04.033.041S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/09/2018
• Supplement Date Received by Manufacturer: 06/05/2018
• Initial Report FDA Received Date: 04/30/2018
• Supplement Report FDA Received Date: 06/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1