MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA SCREW 85MM - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.038.085S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	07/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier, date of birth, gender, and weight not available for reporting device malfunctioned intra-operatively and was not implanted / explanted.Complainant part is not expected to be returned for manufacturer review/investigation.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 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) tfna screw.This is report 2 of 3 for (b)(4).

• Brand Name: TFNA SCREW 85MM - STERILE
• 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: 7779474
• Report Number: 2939274-2018-53311
• Device Sequence Number: 13773144
• Product Code: HSB
• UDI-Device Identifier: 10886982098450
• UDI-Public: (01)10886982098450
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K131548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/29/2018

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: 04.038.085S
• Device Catalogue Number: 04.038.085S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2018
• Initial Report FDA Received Date: 08/13/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 17 YR