MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LOCKSCR Ø4 L42 F/NAILS TAN DBLUE; SCREW,FIXATION,BONE

Model Number	04.005.432
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier, date of birth, age, gender and weight were not available for reporting.Additional procode: hsb device was not implanted.Complainant device is not expected to be returned for manufacturer review/investigation.Reporter title is orthopedics coordinator.Patient code (b)(4) used to capture additional medical/surgical intervention required due to change in surgical plan.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 screws would not go in the aiming arm when the surgeon was attempting to insert the proximal locking screws in an adolescent femoral nail during an intramedullary nail of a femur on (b)(6) 2018.The sales consultant further explained that the aiming arm would accept the drill bit, but not the screws.The insertion handle and/or the aiming arm kept the protection sleeve from lining up properly, which eventually led to the transverse interlock not working properly and they had to switch the hole and use the antegrade interlock to lock the screw and complete the procedure.The procedure was successfully completed with no surgical delay.The patient was fine at the end of the procedure.Concomitant device (s) reported:12.0mm/8.0mm protection sleeve (part # 03.010.063, unknown lot #, qty # 1).This report is for one (1) locking screw.This is report 1 of 3 for (b)(4).

• Brand Name: LOCKSCR Ø4 L42 F/NAILS TAN DBLUE
• Common Device Name: SCREW,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7393710
• Report Number: 2939274-2018-51412
• Device Sequence Number: 1575060
• Product Code: HWC
• UDI-Device Identifier: 10886982085443
• UDI-Public: (01)10886982085443(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K103002
• 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): 03/07/2018

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 Model Number: 04.005.432
• Device Catalogue Number: 04.005.432
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/07/2018
• Initial Report FDA Received Date: 04/03/2018
• 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