MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DHS/DCS ONE-STEP LAG SCR 12.7 THRD/85-S; DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT

Model Number 280.285S

Device Problem Break (1069)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/21/2018

Event Type  Injury  

Manufacturer Narrative

Additional product code: ktt.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 Description

It was reported that on (b)(6) 2018 , the patient had wi fracture of her intertrochanteric hip area and underwent an open reduction internal fixation surgery.Procedure was completed successfully.On or about (b)(6) 2020, two years following her hip procedure, she was returning home and inside of her garage her hip gave out.Patient then saw her surgeon to describe the issue to him and x-rays were completed which revealed that the screws had all broken and the plate connecting the hip had pulled away from her femur with fracturing.The patient immediately went into another surgery to rectify the situation.It was detailed that all the screws that were inserted had failed over the two year period since her initial surgery.Patient underwent revision surgery for the removal of hardware and the femoral fracture was re-plated utilizing screws from another manufacturer.This report is for one (1) dhs/dcs one-step lag screw 12.7mm thread/85mm-sterile.This is report 1 of 6 for complaint (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H6 - codes updated to imdrf codes.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.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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

The patient was revised on (b)(6) 2020 to remove the broken screw heads.

• Brand Name: DHS/DCS ONE-STEP LAG SCR 12.7 THRD/85-S
• Type of Device: DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11838246
• MDR Text Key: 262154043
• Report Number: 2939274-2021-02391
• Device Sequence Number: 1
• Product Code: JDO
• UDI-Device Identifier: 10886982175144
• UDI-Public: (01)10886982175144
• Combination Product (y/n): N
• PMA/PMN Number: K964259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 280.285S
• Device Catalogue Number: 280.285S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/25/2021
• Patient Sequence Number: 1
• Treatment: CORTSCR Ø4.5 SELF-TAP L38 SST; CORTSCR Ø4.5 SELF-TAP L38 SST; CORTSCR Ø4.5 SELF-TAP L38 SST; UNK - PLATES; UNK - SCREWS: TRAUMA
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR