MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM TI CANNULATED TIBIAL NAIL-EX/360MM-STERILE; NAIL,FIXATION,BONE

Model Number	04.004.452S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not expected to be returned for manufacturer review/investigation.(b)(4).Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 an unknown date, the surgeon was having issues with the suprapatellar nail cases.First issue, was with extreme difficulty in disengaging the connecting screw that attached the insertion handle to the nail at the end of the case.This appears to be caused by bending forces on the insertion handle connection to the nail which in turn increases the friction of the connecting screw threads with the threads in the nail.Second issue, was miss targeting of the proximal holes in the nail.The issue was after nail insertion and appears there were forces being applied to the construct that cause flex between the insertion handle and the nail.When using the long insertion handle, the targeting arm seems to misfire and the drill bit seems to hit the nail when prepping for proximal locking screws.The connecting bolt required a wrench with the ball tip hex to remove from the nail.There was no issue on the back table and everything aligns.Procedure was successfully completed with the delay of 5 minutes.Patient status is fine.This report is for one (1) cannulated tibial nail.This is report 2 of 5 for (b)(4).

• Brand Name: 10MM TI CANNULATED TIBIAL NAIL-EX/360MM-STERILE
• 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: 8492702
• Report Number: 2939274-2019-57357
• Device Sequence Number: 13820873
• Product Code: JDS
• UDI-Device Identifier: 10886982084231
• UDI-Public: (01)10886982084231
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K040762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.004.452S
• Device Catalogue Number: 04.004.452S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 04/08/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention