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

Model Number	02.124.418
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: CONDYLAR PLATE FIXATION IMPLANT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11814509
• Report Number: 2939274-2021-02346
• Device Sequence Number: 3738611
• Product Code: JDP
• UDI-Device Identifier: 10886982042972
• UDI-Public: (01)10886982042972
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K083025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/15/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02.124.418
• Device Catalogue Number: 02.124.418
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 05/12/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention