MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ELBOW HINGE FIXATOR; APPLIANCE,FIXATION,NAIL

Model Number	394.055
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event occurred on an unknown date in 2019.Additional product code: lxt.Device was explanted on an unknown date in 2019.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 or Problem Description
It was reported that on an unknown date, the elbow hinge fixator broke in the patient.Implant was removed.Initial date of surgery was on (b)(6) 2019.It is unknown if there was surgical delay.Procedure and patient outcome was unknown.Concomitant device reported: unknown external-fixator clamps (part # unknown, lot # unknown, quantity # 1); unknown rods (part # unknown, lot # unknown, quantity # unknown).Unknown schanz screws (part # unknown, lot # unknown, quantity # unknown).This is report 1 of 1 for (b)(4).

• Brand Name: ELBOW HINGE FIXATOR
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8695924
• Report Number: 2939274-2019-58627
• Device Sequence Number: 2005475
• Product Code: KTT
• UDI-Device Identifier: 10886982199478
• UDI-Public: (01)10886982199478
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K090658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 394.055
• Device Catalogue Number: 394.055
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 06/13/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - EX-FIX CLAMPS; UNK - RODS; UNK - SCHANZ SCREWS
• Outcome Attributed to Adverse Event: Required Intervention