MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; ROD,FIXATION,INTRAMEDULLARY

Device Problem Device-Device Incompatibility (2919)

Patient Problem Not Applicable (3189)

Event Date 07/29/2018

Event Type  Injury  

Manufacturer Narrative

Patient identifier, date of birth, gender, and weight not available for reporting this report is for an unknown aiming arm/unknown lot.Part and lot numbers are unknown; udi number is unknown.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but 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 patient underwent a trochanteric fixation nail advanced (tfna) procedure for a left femur shaft fracture on (b)(6) 2018.During the procedure, the fracture was anatomically reduced.Surgeon reamed 1.5mm over the diameter of the nail.While attempting to rotate the nail within the canal, surgeon applied heavy torque to the aiming arm attached to the nail.When the lag screw was drilled for and implanted, the lateral x-ray confirmed the lag screw was outside the nail.The screw was removed and surgeon reattempted to tighten the coupling screw back to the top of the nail to then re-insert the lag screw, but the lag screw still missed the nail.Surgeon opted to leave the lag screw out and used two (2) distal locking screws.Surgery was completed successfully with a delay of approximately 10 minutes.This report is for one (1) unknown aiming arm.This is report 3 of 3 for (b)(4).

• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7779481
• MDR Text Key: 117000649
• Report Number: 2939274-2018-53312
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 17 YR