MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/LEFT; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Model Number 02.124.415

Device Problem Device-Device Incompatibility (2919)

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

Event Date 12/02/2021

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2021, while plating a distal femur the variable angle locking screw on the variable angle locking compression plate (va-lcp) curved condylar plate cross threaded and did not lock into the plate properly.There was no surgical delay.The procedure was successfully completed.There was no patient consequence reported.This complaint involves (2) devices.This report is for (1) 4.5mm va-lcp curved condylar plate/14 hole/301mm/left.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Additional product code: hrs, hwc.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.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: 4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/LEFT
• 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
• 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: 13122456
• MDR Text Key: 284869403
• Report Number: 2939274-2021-07331
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 10886982042910
• UDI-Public: (01)10886982042910
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.124.415
• Device Catalogue Number: 02.124.415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 5.0 VA LOCKNG SCR SLF-TPNG/SD/70
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Weight: 58 KG