MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DHS/DCS ONE-STEP LAG SCREW 12.7MM THREAD/80MM; DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT

Model Number 280.280

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

Additional product code: ktt.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.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, the patient underwent a procedure due to fracture that occurred below two hole dynamic hip system (dhs) plate.The dhs was removed easily, and a trochanteric femoral nailing advanced (tfna) was used to repair the fracture.This report is for one (1) dhs/dcs one-step lag screw 12.7mm thread/80mm.This is report 2 of 4 for complaint (b)(4).

• Brand Name: DHS/DCS ONE-STEP LAG SCREW 12.7MM THREAD/80MM
• 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
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12509403
• MDR Text Key: 272572230
• Report Number: 2939274-2021-05685
• Device Sequence Number: 1
• Product Code: JDO
• UDI-Device Identifier: 10886982175113
• UDI-Public: (01)10886982175113
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/24/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: 280.280
• Device Catalogue Number: 280.280
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2021
• Initial Date FDA Received: 09/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 130 DEG DHS PL-STD BARREL 2 HOLES/46-S; UNK - SCREWS: 4.5 MM CORTEX; UNK - SCREWS: 4.5 MM CORTEX
• Patient Outcome(s): Required Intervention