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

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

Patient Problem Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

Patient identifier, weight, and ethnicity not available for reporting.Date of fracture is not known.This report is for an unknown va condylar plate/unknown lot.Part and lot numbers are unknown; udi number is unknown.Date of implant is not known.Explant of the plate was not reported.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.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) 2018, patient underwent a removal of a trochanteric fixation nail advanced (tfna) due to a fracture that occurred at a point of a stress riser between the tfna nail and a variable angle (va) condylar plate.The tfna nail was easily removed and replaced with a new, longer tfna nail which extended beyond the plate.An unknown quantity of cables were also placed to augment the construct, as well as an unknown quantity of screws.No fragments were produced.It is not known if surgery was delayed.Patient outcome is not known.This report is for one (1) unknown va condylar plate.This is report 5 of 5 for (b)(4).

• 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 Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7782798
• MDR Text Key: 117130524
• Report Number: 2939274-2018-53330
• Device Sequence Number: 1
• Product Code: JDP
• 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: 07/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2018
• 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
• Patient Age: 86 YR