MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - SCREWS: RECON; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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

Patient Problem Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown femoral recon nail (frn) screw/unknown lot.Part and lot number are unknown; udi number is unknown.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 on an unknown date, the patient underwent an antegrade intramedullary procedure for highly comminuted segmental femoral shaft fracture with associated injury of t1, t6-9 tp fracture, l5 tp fracture, l 7th rib fracture, liver laceration, l femur fracture, b/l acetabulum fracture, r posterior iliac fracture, l sacroiliac joint widening, b/l superior and inferior pubic rami fracture, l distal humerus fracture, l ulnar and radius fracture, r midshaft radius and ulnar fracture, duodenal hematoma, serosal tear to transverse colon x2, morel lavallee lesion.There was infection but there was no delayed union of fracture.Other complication includes heterotopic ossification near some of the interlocking screws exuberant callus formation from the fracture and also some heterotopic bone from the external fixator pin sites.A reoperation including wound vac and revision of distal locking screws was performed.Patient outcome is unknown.No further information is available.This report is for an unknown femoral recon nail (frn) screw.This is report 2 of 2 for (b)(4).

• Brand Name: UNK - SCREWS: RECON
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12385783
• MDR Text Key: 268731833
• Report Number: 2939274-2021-05001
• Device Sequence Number: 1
• Product Code: HSB
• 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: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• 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: 08/11/2021
• 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
• Treatment: UNK - NAILS: FRN
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR