MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RADIOLUCENT RECON AIMING ARM FOR EXPERT ALFN; ROD, FIXATION, INTRAMEDULLARY

Model Number 03.010.483

Device Problem Failure to Align (2522)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/11/2018

Event Type  malfunction  

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 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 recon aiming arm for expert alfn.This is report 2 of 2 for complaint (b)(4).

• Brand Name: RADIOLUCENT RECON AIMING ARM FOR EXPERT ALFN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7498364
• MDR Text Key: 107863414
• Report Number: 2939274-2018-52105
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982069016
• UDI-Public: (01)10886982069016
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070843
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 03.010.483
• Device Catalogue Number: 03.010.483
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2018
• Initial Date FDA Received: 05/09/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1