MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED SCREW 80MM - STERILE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	04.038.180S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device product codes: hsb.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 on an unknown date, the surgeon performed surgery on a right reverse oblique subtrochanteric femur fracture.The surgeon implanted a 125-degree tfna nail, 80mm tfna lag screw, and two 5.0mm locking screws.The surgeon noticed that post op xray shows that the lag screw appears to be broken and about halfway in the threaded portion of one of the fenestrated holes.The original date of implantation was on (b)(6) 2019.The procedure and patient outcomes were unknown.Concomitant devices reported: 10mm/125 deg ti cann tfna 360mm/right - sterile (part number 04.037.026s, lot unknown, quantity 1), 5.0mm ti locking screw 44mm- for im nails-sterile (part number 458.944s, lot unknown, quantity 1), 5.0mm ti locking screw 42mm- for im nails-sterile (part number 458.942s, lot unknown, quantity 1).This report involves one (1) tfna fenestrated screw 80mm ¿ sterile.This is report 1 of 1 for (b)(4).

• Brand Name: TFNA FENESTRATED SCREW 80MM - STERILE
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10459195
• Report Number: 2939274-2020-03813
• Device Sequence Number: 11567685
• Product Code: KTT
• UDI-Device Identifier: 10886982098696
• UDI-Public: (01)10886982098696
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/02/2020

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: 04.038.180S
• Device Catalogue Number: 04.038.180S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2020
• Initial Report FDA Received Date: 08/27/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 10MM/125 DEG TI CANN TFNA 360MM/RIGHT - STERILE; 5.0MM TI LOCKING SCREW 42MM- FOR IM NAILS-STERILE; 5.0MM TI LOCKING SCREW 44MM- FOR IM NAILS-STERILE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Weight: 64