MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM VA-LCP CURVED CONDYLAR PLATE/18 HOLE/370MM/RIGHT; CONDYLAR PLATE FIXATION IMPLANT

Catalog Number 02.124.418

Device Problem Break (1069)

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Additional product code: hrs, hwc.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.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

Device report from synthes reports an event in (b)(6) as follows: it was reported, by a disappointed and frustrated surgeon that three of his patients, plus two patients of his colleague surgeon (for a total of five patients) who have experienced a 4.5mm variable angle lcp (va-lcp) curved condylar bridge plate construct failure after very short time and had to go for a post-op surgery in the management of highly comminuted distal femoral fracture.I was only told of these five fractures today but these construct failures have happened in last few months.Surgeon has promised to supply more information shortly and suspect that the combi hole four column threads maybe the source of a stress riser, at screw/plate junction failure.Procedure was completed successfully without any delay.This report is for one (1) 4.5mm va-lcp curved condylar plate/18 hole/370mm/right.This is report 1 of 2 for (b)(4).

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/18 HOLE/370MM/RIGHT
• Type of Device: CONDYLAR PLATE FIXATION IMPLANT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11812864
• MDR Text Key: 250231831
• Report Number: 2939274-2021-02339
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 07611819454149
• UDI-Public: (01)07611819454149
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K083025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2021
• 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 - SCREWS: TRAUMA
• Patient Outcome(s): Required Intervention