MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - SCREWS: TRAUMA; SCREW,FIXATION,BONE

Device Problem Device Slipped (1584)

Patient Problems Non-union Bone Fracture (2369); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown trauma screw.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.Initial reporter is company representative.(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) 2015, a patient underwent open reduction with internal fixation ("orif") procedures at university hospital, among other things, to these body parts.A synthes plate with locked screws was utilized during the procedures.It was necessary for the patient to undergo several procedures thereafter related to open wound conditions and debridement.On (b)(6) 2015, the patient was involved in a motorcycle accident and suffered fractures to his left femur, as well as the left closed metatarsal and toes.During one such procedure, which took place on (b)(6) 2016, as a result of left distal femur fracture nonunion, it was noted that a 2.4 screw was loose, and it had to be removed.This complaint involves one (1) device.This report is for one (1) unknown trauma screws.This is report 1 of 1 for (b)(4).(b)(4) captures the initial surgery of the patient who suffered fractures to the patient's left femur and a 2.4 screw was loose while (b)(4) captures the first revision of the heads of two of the screws were broken off the screws themselves and a 2.0 plate was separately located elsewhere around the femur, and it was also removed and (b)(4) captures the second revision of a nonunion due to hardware failure.

• Brand Name: UNK - SCREWS: TRAUMA
• Type of Device: SCREW,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: 9518167
• MDR Text Key: 172722203
• Report Number: 2939274-2019-62784
• Device Sequence Number: 1
• Product Code: HWC
• 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,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2019
• 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
• Patient Outcome(s): Required Intervention