MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5 VA-LCP CURVED COND PL/18 HOLE/370/RT; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Model Number 02.124.418

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/02/2021

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2021, during an unknown procedure for a distal femur fracture, the surgeon was complaining about the plate fit and how far the plate on the plate was setting off the bone.She accepted the plate setting off the bone.There was no surgical delay.The procedure was successfully completed.There were no patient consequences.This complaint involves one (1) device.This report is for one (1) 4.5 va-lcp curved cond pl/18 hole/370/rt.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).(b)(6).Additional product code: hwc hrs.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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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.

• Brand Name: 4.5 VA-LCP CURVED COND PL/18 HOLE/370/RT
• Type of Device: IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12707927
• MDR Text Key: 284683203
• Report Number: 2939274-2021-06338
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 10886982042972
• UDI-Public: (01)10886982042972
• Combination Product (y/n): N
• PMA/PMN Number: K110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 10/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.124.418
• Device Catalogue Number: 02.124.418
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/02/2021
• Initial Date FDA Received: 10/27/2021
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 81