MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; SCREW,FIXATION,BONE

Device Problems Break (1069); Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown screw/unknown lot.Part and lot numbers are unknown; udi number is unknown.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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: n.Cutrera and c.Collinge (2016).A comparative cohort study of mechanical failure for monoaxial and polyaxial locking plates in the treatment of ota 33-a and 33-c distal femur fractures.Scientific poster #23 knee and tibial plateau ota 2016.Page 381-382.(usa).The aim of this study is to compare mechanical failure rates in patients with distal femur fractures treated with of early and later generations of locking plates (liss, lcps, and va-lcps).Our secondary aims are to describe modes, timing, and risks of failure in these cases.This retrospective case-control series evaluates mechanical fixation failure patients with ota 33-a and c distal femur fractures treated with locked plating at a single level i trauma center from 2010 to 2015.170 of these patients were treated with a titanium monoaxial unicortical screw and plate system designed for minimally invasive application (liss, depuy synthes); stainless steel monoaxial lcp (periloc, smith & nephew; and locking condylar plate, depuy synthes; or a stainless steel ¿variable-angle¿ lcp (va-lcp, depuy synthes).148 cases were included for this study.Patient and injury factors were evaluated.Serial radiographs were analyzed for mechanical failure including implant breakage, bending, loosening, or change in alignment (>5°).Secondary outcome measures were modes of failure, time to failure, and risk factors for failure.The following complications were reported as follows: there were a total number of 23 mechanical failures, including 6 of 37 liss, 4 of 47 lcps, and 13 of 64 va-lcps.In the liss group, all failures consisted of screw breakage or loosening.3/4 (75%) failures were attributable to screw breakage or loosening in the lcp group.The most common mode of failure in the va-lcp group was change in alignment, with 8/13 collapsing into varus.This report is for an unknown synthes screw.This is report 1 of 3 for (b)(4).

• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8363590
• MDR Text Key: 136922650
• Report Number: 2939274-2019-56625
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2019
• 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 Outcome(s): Required Intervention