MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - CONSTRUCTS: PLATE/SCREWS; PLATE, FIXATION, BONE

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

Patient Problems Reaction (2414); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown plate/screws constructs/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.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

This report is being filed after the review of the following journal article: hussain, m., kakazu, r., jimenez, a., and wyrick, j.(2020), proximal cortical breach after retrograde femoral nailing for femoral shaft fracture.A case report, jbjs case connect, vol.10 (1), pages 1¿5 (usa).This study presents a case report of a (b)(6) year-old male patient who sustained a comminuted, distal diaphyseal femoral shaft fracture (ao/ota 32b1) was treated with retrograde nailing.It was complicated by proximal cortical breach.The proximal fracture was detected intraoperatively and treated with plating.A 9-hole synthes less invasive stabilization system (liss) plate was chosen to buttress the fracture fragment while avoiding extensive soft-tissue dissection (fig.2-e).Postoperatively, the patient ambulated with weight of leg foot flat restrictions.His medical complications including delirium and acute kidney injury were managed medically, and he was discharged to a rehabilitation facility.He gradually advanced his weight-bearing, walking with a cane at 6 weeks postoperative.By 4 months, the patient had returned to work and was able to walk with a slight limp without assistive devices.Radiographs at 8 months postoperative demonstrate healing of both fractures, proximal and distal (figs.3-a through 3-d).At the latest follow-up, a discussion was made regarding the removal of the proximal plate on an elective basis because of irritation at the hip from the liss plate.This report is for an unknown synthes plate/screws constructs.This is report 1 of 1 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PLATE/SCREWS
• Type of Device: PLATE, FIXATION, BONE
• 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: 10742283
• MDR Text Key: 213397622
• Report Number: 2939274-2020-04838
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• 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: 09/29/2020
• 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
• Patient Age: 70 YR