MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - CONSTRUCTS: DHHS; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

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

Patient Problems Necrosis (1971); Non-union Bone Fracture (2369); Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown construct/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number the device history records review could not be completed.Product was not returned.The investigation could not be completed; no conclusion could be drawn, as no product was received.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

This report is being filed after the review of the following journal article: marchand, l.S.Et al.(2021), fixed angle device comparison in young femoral neck fractures: dynamic hip screw vs dynamic helical hip system, injury, vol.Xx, pages 1-6 (usa) this investigation sought to compare the complication profile of these two fixed-angle implants (dhs and dhhs).From january 2007 to february 2019, a total of 133 skeletally mature patients under the age of 60 years were treated for an acute femoral neck fracture.58 were treated with dhs and 75 were treated with dhhs.The average age of patients was 38 years (range: 18¿59).Patients were followed for a minimum of 12 months from the time of fracture fixation.The following complications were reported as follows: dhs 10 patients had femoral neck shortening (>5 mm), 3 patients had non-union requiring osteotomy, 6 patients had conversion to tha, 1 patient had osteonecrosis, reduction quality: (1) fair, dhhs 4 patients had femoral neck shortening (>5 mm), 1 patient had non-union requiring osteotomy, 5 patients had conversion to tha, 2 patients had osteonecrosis, this report is for an unknown synthes dhs and dhhs.

• Brand Name: UNK - CONSTRUCTS: DHHS
• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13695356
• MDR Text Key: 292490426
• Report Number: 2939274-2022-00809
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention