MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TFNA 400MM/LEFT - STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.037.161S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(b)(4).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 that the patient underwent revision surgery on (b)(6) 2018 due to non-union and broken hardware.The trochanteric femoral nail-advance (tfna) nail was broken at the entry point of the helical blade; the two (2) tfna locking screws at the end of the nail were also broken.All the implants were removed except for half of a locking screw.Patient was revised with another tfn, helical blade and two (2) locking screws.The surgeon also implanted antibiotics, calcium sulfate, and bone graft material.Procedure outcome and patient status is unknown.The patient was originally treated by a different surgeon on (b)(6) 2016 for a comminuted subtrochanteric fracture on the left leg using a tfna helical blade, nail, two (2) 5.0 locking screws, as well as a cable with crimp.The revision surgeon said that the nail breakage was due to the technique of the previous surgeon putting a cable above the lesser trochanter, cutting off blood supply and not allowing the bone to heal.Concomitant devices: tfna 90mm helical blade (part: 04.038.290, lot: unknown, quantity: 1); 1.7mm cable with crimp 750mm (part: 298.801.01s, lot: unknown, quantity: 4).This report is for an titanium (ti) cannulated tfna nail.This is report 1 of 2 for (b)(4).

• Brand Name: 11MM/130 DEG TI CANN TFNA 400MM/LEFT - 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: 8025388
• Report Number: 2939274-2018-54707
• Device Sequence Number: 19131345
• Product Code: HSB
• UDI-Device Identifier: 10886982096692
• UDI-Public: (01)10886982096692
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/16/2018

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: 04.037.161S
• Device Catalogue Number: 04.037.161S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2018
• Initial Report FDA Received Date: 10/31/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention