MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM VA-LCP CURVED CONDYLAR PLATE/10 HOLE/230MM/LEFT; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Model Number 02.124.411

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional device product code: hwc; hrs.Complainant part is not expected to be returned for manufacturer review/ investigation.(b)(4).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) 2017, the patient underwent a revision of distal left femur open reduction and internal fixation with bone grafting and lateral plate and screw fixation for fracture nonunion.Preoperatively, images revealed a displaced distal femur fracture nonunion with broken hardware.The plate was broken.All screws were removed as well as the broken plate.It was found out that there was fibrous union tissue seen within the comminuted area and an attritional bone loss consistent with atrophic areas of nonunion and was implanted with a 4.5 mm valcp cond plate and a 3.5 x 32mm self-tap screw.Initially on (b)(6) 2016, the patient underwent an open reduction internal fixation left distal femur fracture due to deformity and pain in the left thigh sustained from a fall while on vacation.X-rays and ct revealed an intra-articular fracture involving the left femur.The patient was implanted with depuy synthes implants.Postoperatively, on (b)(6) 2016, radiographs show a healing fracture post plate and screw osteosynthesis.Interval callus formation is noted with acceptable alignment but still has delayed union.No hardware complications or other acute findings.On (b)(6) 2017, the patient's condition was getting improvement and was able to ambulate w/ assistance of a cane.Unfortunately, he slipped on a wet cement floor and had a fall and injured the left knee.He heard a pop at the knee and since then he had severe pain and has been unable to place weight on his left lower extremity which led to revision procedure on (b)(6) 2017.This report captures first revision performed on (b)(6) 2017 due to broken plate, while related complaint (b)(4) captures the second revision which was performed on (b)(6) 2018 due to non-union.Concomitant device reported: 5.0mm variable angle locking screw 75mm (part # 02.231.275, lot # unknown, quantity 2); 5.0mm variable angle locking screw 55mm (part # 02.231.255, lot # unknown, quantity 1); 5.0mm variable angle locking screw 80mm (part # 02.231.280, lot # unknown, quantity 2); 5.0mm variable angle locking screw 85mm (part # 02.231.285, lot # unknown, quantity 1); 4.5mm cortex screw self-tapping 40mm (part # 214.840, lot # unknown, quantity 2); 4.5mm cortex screw self-tapping 42mm (part # 214.842, lot # unknown, quantity 1); 4.5mm cortex screw self-tapping 44mm (part # 214.844, lot # unknown, quantity 1).This report is for one (1) 4.5mm va-lcp curved condylar plate/ 10 hole/ 230mm/ left.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h4, h6: 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.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.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.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10: additional narrative: b6, e1, h6 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.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10: additional narrative: h3, h6: a photo investigation was completed: visual analysis of the photo revealed that the plate had broken at the third combi-hole from the condylar end.The material condition is unable to be analyzed since no images of the broken ends were returned, and the device was also not returned.The complaint condition is consistent with fracture due to additional trauma, unexpected excessive forces, and atrophic non-union.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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/10 HOLE/230MM/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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9622773
• MDR Text Key: 176092027
• Report Number: 2939274-2020-00375
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 10886982042835
• UDI-Public: (01)10886982042835
• 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: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.124.411
• Device Catalogue Number: 02.124.411
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/07/2023
• 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
• Treatment: 4.5MM CORTEX SCREW SELF-TAPPING 40MM; 4.5MM CORTEX SCREW SELF-TAPPING 40MM; 4.5MM CORTEX SCREW SELF-TAPPING 42MM; 4.5MM CORTEX SCREW SELF-TAPPING 44MM; 5.0MM VARIABLE ANGLE LOCKNG SCREW 55MM; 5.0MM VARIABLE ANGLE LOCKNG SCREW 75MM; 5.0MM VARIABLE ANGLE LOCKNG SCREW 75MM; 5.0MM VARIABLE ANGLE LOCKNG SCREW 80MM; 5.0MM VARIABLE ANGLE LOCKNG SCREW 80MM; 5.0MM VARIABLE ANGLE LOCKNG SCREW 85MM; 4.5MM CORTEX SCREW SELF-TAPPING 40MM; 4.5MM CORTEX SCREW SELF-TAPPING 40MM; 4.5MM CORTEX SCREW SELF-TAPPING 42MM; 4.5MM CORTEX SCREW SELF-TAPPING 44MM; 5.0MM VARIABLE ANGLE LOCKNG SCREW 55MM; 5.0MM VARIABLE ANGLE LOCKNG SCREW 75MM; 5.0MM VARIABLE ANGLE LOCKNG SCREW 75MM; 5.0MM VARIABLE ANGLE LOCKNG SCREW 80MM; 5.0MM VARIABLE ANGLE LOCKNG SCREW 80MM; 5.0MM VARIABLE ANGLE LOCKNG SCREW 85MM
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White