MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC VA-LCP; CONDYLAR PLATE FIXATION IMPLANT

Model Number 02.124.418

Device Problem Break (1069)

Patient Problem Non-union Bone Fracture (2369)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional pro-code: hrs & hwc.Investigation summary: 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.Complainant part is not expected to be returned for manufacturer review.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Device history lot: part: 02.124.418, lot: 8675554, manufacturing site: (b)(4), release to warehouse date: 17 oct 2013.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 an unknown date, during an unknown procedure, variable angle condylar plate and one cable broke.It is unknown if there was surgical delay.Procedure outcome is unknown.No patient consequence.This complaint involves two (2) devices.This report is for one (1) 4.5 va-lcp curved cond pl/18 hole/370/rt.This report is 1 of 2 for (b)(4).

• Brand Name: VA-LCP
• 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 west chester; west chester, PA
• MDR Report Key: 11872484
• MDR Text Key: 252399296
• Report Number: 2939274-2021-02526
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.124.418
• Device Catalogue Number: 02.124.418
• Device Lot Number: 8675554
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention