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

Model Number 02.124.414

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/25/2020

Event Type  malfunction  

Manufacturer Narrative

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.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

It was reported that on (b)(6) 2020 during an open reduction internal fixation (orif) of a distal femur fracture the 4.5mm variable angle locking compression plate condylar system was used.During the operation the connecting bolt for the percutaneous outrigger failed to attach to the 4.5mm variable angle locking compression plate curved condylar plate/14 hole/301mm/right.There were no issues with attachment to any other length plate in the system and a second instrument set opened during the case produced the same result.The 14 hole plate was used without the outrigger, causing minimal delay, but greatly increasing surgical difficulty.Additionally, the handle for percutaneous threaded drill guides would properly attach to the drill guides.This was remedied with minimal delay through the use of the second instrument set.There was a surgical delay of twenty (20) minutes.Procedure was successfully completed.There is no patient consequence reported.This report is for one (1) 4.5mm va-lcp curved condylar plate/14 hole/301mm/right.This is report 1 of 4 for (b)(4).

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/RIGHT
• 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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10427348
• MDR Text Key: 204259134
• Report Number: 2939274-2020-03643
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 10886982042897
• UDI-Public: 10886982042897
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.124.414
• Device Catalogue Number: 02.124.414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2020
• Initial Date FDA Received: 08/19/2020
• 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
• Patient Age: 94 YR
• Patient Weight: 84