MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM CORTEX SCREW SELF-TAPPING 40MM; NAIL,FIXATION,BONE

Model Number	204.840
Medical Device Problem Codes	Break (1069); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional procode: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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.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 (b)(6) 2020, the patient underwent a removal procedure due to a non-union secondary to a broken hardware.A pre-op x-ray was taken and showed 3 va locking screws were broken.During the removal procedure, 4 variable locking screws and 3 cortex screws were removed.1 broken va locking screw and the 3.5 anterolateral right 15 hole plate were left in the patient.The surgeon implanted a tibia nail from smith and nephew to fix the fracture.The procedure was successfully completed with 5 minutes surgical delay.Patient status was unknown.Concomitant device reported: lcp anterolateral distal tibial plate (part # 241.45, lot # unknown, quantity 1).This report is for 1 3.5mm cortex screw self-tapping 40mm.This is report 6 of 9 for (b)(4).
Event or Problem Description
It was clarified that four (4) variable locking screws and three (3) cortex screws were removed but not broken.Three (3) of the locking screws were broken.Two (2) of the broken screws were removed; one (1) broken screw and the 3.5 anterolateral right 15-hole plate were left in the patient.

• Brand Name: 3.5MM CORTEX SCREW SELF-TAPPING 40MM
• Common Device Name: NAIL,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10763550
• Report Number: 2939274-2020-04906
• Device Sequence Number: 14324094
• Product Code: JDS
• UDI-Device Identifier: 10886982146380
• UDI-Public: (01)10886982146380
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K112583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2020

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: 204.840
• Device Catalogue Number: 204.84
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 10/30/2020
• Supplement Report FDA Received Date: 12/01/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3.5MM CORTEX SCREW SELF-TAPPING 40MM.; 3.5MM CORTEX SCREW SELF-TAPPING 40MM.; 3.5MM LCP ANTEROLATERAL DISTAL TIBIA PL 15 HOLES.; 3.5MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV.; 3.5MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV.; 3.5MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV.; 3.5MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV.; 3.5MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV.; UNK - SCREWS: TRAUMA.; 3.5MM CORTEX SCREW SELF-TAPPING 40MM; 3.5MM CORTEX SCREW SELF-TAPPING 40MM; 3.5MM LCP ANTEROLATERAL DISTAL TIBIA PL 15 HOLES; 3.5MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV; 3.5MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV; 3.5MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV; 3.5MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV; 3.5MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV; UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR