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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown plate/unknown lot.Part and lot number are unknown; udi number is unknown.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.The investigation could not be completed; no conclusion could be drawn, as no product was received.(b)(4).Delayed union and nonunion there is no mention in the article about a revision surgery.Investigation summary: 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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: parks, c.Et al (2018), in-vivo stiffness assessment of distal femur fracture locked plating, clinical biomechanics 56, pages 46-51 (usa).The purpose of this study was to design and validate a novel stiffness-measuring device using locked plating of distal femur fractures as a model.From october 2012 to july 2015, 27 patients with distal femur fractures with the operative plan of locked distal femur plating were prospectively enrolled into this study.Fourteen of twenty-seven patients enrolled with distal femur fractures (ao/ota 33a and 33c) completed the study.All patients underwent a laterally-based approach, with a bridging locked construct after indirect reduction.Patients were excluded if the plate was not the 4.5mm va-lcp distal femur plate (synthes, west chester, pa).All patients were followed clinically for one year, standard follow up 2 weeks, 6 weeks, 3, 6, and 12 months and data were collected including radiographic and clinical union, patient-reported functional outcomes lower extremity measure (lem) scale, fixation failure, postoperative infection, delayed or nonunion, and unplanned return to the operating room.The following complications were reported as follows: 1 had delayed union.2 had an aseptic nonunion.This report is for an unknown synthes 4.5mm va-lcp distal femur plate.This is report 1 of 1 for (b)(4).A copy of the literature article is being submitted with this medwatch.

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.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.

• Type of Device: CONDYLAR PLATE FIXATION IMPLANT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8274355
• MDR Text Key: 133994189
• Report Number: 2939274-2019-56038
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 01/24/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention