MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM/3.5MM VA-LCP LAT ANT CLAVICLE PLATE/10 HOLE/101MM; PLATE, FIXATION, BONE

Model Number 02.112.047

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

Patient Problem Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/ investigation.Reporter is a j&j employee.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 fracture fixation for a lateral fracture utilizing a va-lcp anterior plate.There was a union of fracture after 6 weeks duration and no post-operative complications reported.Patient was re-operated due to hardware removal and could feel implant.Concomitant device reported: unk - screws: cortex (part # unknown; lot # unknown; quantity: unknown).This report is for one (1) 2.7mm/3.5mm va-lcp lat ant clavicle plate/10 hole/101mm.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 2.7MM/3.5MM VA-LCP LAT ANT CLAVICLE PLATE/10 HOLE/101MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12384955
• MDR Text Key: 268706181
• Report Number: 2939274-2021-04991
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982033031
• UDI-Public: (01)10886982033031
• Combination Product (y/n): N
• PMA/PMN Number: K101536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/23/2021

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: 02.112.047
• Device Catalogue Number: 02.112.047
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/27/2021
• Initial Date FDA Received: 08/30/2021
• Supplement Dates Manufacturer Received: 09/21/2021
• Supplement Dates FDA Received: 09/21/2021
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: CORTEX.; UNK - SCREWS: CORTEX
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR