MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RADIOLUCENT INSERTION HANDLE FOR EXPERT ALFN/100MM; ROD, FIXATION, INTRAMEDULLARY

Model Number	03.010.488
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is not available for reporting.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter¿s phone number is not provided for reporting.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 femur open reduction and internal fixation (orif) performed on (b)(6) 2018 for an unknown patient the surgeon was assembling the adolescent lateral femoral nail (alfn) when it was noted the proximal interlocks weren¿t lining up in the nail through the aiming assembly.The drill was completely missing the nail through the aiming assembly.After the case, the sales consultant inspected the devices and noted the aiming arm to be loose.The aiming arm and connecting arm had some play when fully seated due to wear and tear and the connecting arm to be chipped on the metal clips that connect to the nail.These devices were not used on the patient during the surgery.The surgeon completed the procedure by doing perfect circles.There was no reported surgical delay and no reported patient consequence.Concomitant devices reported: insertion instrument: coupling screw (part # unknown, lot # unknown, quantity 1); alfn nail (part # unknown, lot # unknown, quantity 1).This report is for one (1) radiolucent insertion handle for expert alfn/100mm.This is report 1 of 2 for complaint (b)(4).

• Brand Name: RADIOLUCENT INSERTION HANDLE FOR EXPERT ALFN/100MM
• 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: 7498373
• Report Number: 2939274-2018-52103
• Device Sequence Number: 13940541
• Product Code: HSB
• UDI-Device Identifier: 10886982069061
• UDI-Public: (01)10886982069061
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K070843
• 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): 04/11/2018

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: 03.010.488
• Device Catalogue Number: 03.010.488
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/11/2018
• Initial Report FDA Received Date: 05/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1