MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANN CONNECTING SCR W/INTERNL THRD F/PERCUTAN INSERTN HANDLE; GUIDE

Catalog Number	03.010.146
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information not available for reporting.Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4) - no code available used to capture required intervention and surgical delay of 70 minutes.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 on (b)(6) 2018, a cannulated connecting screw would not release from a suprapatellar nail during a suprapatellar nail procedure of the tibia.Nail and screw removal was done since the cannulated connecting screw would not disengaged from the nail.Thus, x-ray was performed since the nail would not release from the insertion handle because of the cannulated connecting screw, they had to remove all screws from the patient and remove the nail and insert a new nail and new locking screws.When the nail was taken out and a new nail was inserted, the cannulated connecting screw would not release again from the new nail.The tip of the nail (1st nail used) broke off and there were fragments generated from the broken nail.The surgeon didn¿t find the piece until they did a mri the next day.The patient had to be brought back into the or to remove the broken tip, all fragments of the nail tip were removed the next day easily, without difficulty without having to remove the nail.Outcome was reported as fine but there was a 70 minutes delay.Surgery was completed successfully.Concomitant device reported: radiolucent insertion handle for expert nails 100mm (03.010.486, lot number unknown, quantity 1).This report is for one (1) cannulated connecting screw.This is report 2 of 3 for (b)(4).

• Brand Name: CANN CONNECTING SCR W/INTERNL THRD F/PERCUTAN INSERTN HANDLE
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7630807
• Report Number: 2939274-2018-52594
• Device Sequence Number: 11217257
• Product Code: FZX
• UDI-Device Identifier: 10886982067968
• UDI-Public: (01)10886982067968
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 05/24/2018

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 Catalogue Number: 03.010.146
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/24/2018
• Initial Report FDA Received Date: 06/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention