MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC VA-LCP; 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)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• 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: 11872484
• Report Number: 2939274-2021-02526
• Device Sequence Number: 3269156
• Product Code: JDP
• UDI-Device Identifier: 10886982042972
• UDI-Public: (01)10886982042972
• Combination Product (Y/N): N
• Initial Reporter State: NE
• PMA/510(K) Number: K110354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/27/2021

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
• Device Lot Number: 8675554
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 05/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention