MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 7 HOLES/81MM; PLATE,FIXATION,BONE

Model Number	241.371
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not expected to be returned for manufacturer review/investigation.Product was not returned.Device history records review could not be completed without lot number.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.
Event or Problem Description
It was reported that on an unknown date, the patient underwent revision as the trochanteric femoral nail advanced (tfna) broke at the nail/helical blade interface.Patient had a non union fracture, so the nail was replaced with another tfna.In addition, the patient also had a 7 hole one third tubular plate placed on their ulna which also broke post-operative.Patient needed a new tfna and received a distal radius plate along with a 14 hole 3.5 curved lcp plate on their ulna.It is unknown if there was surgical delay.Procedure outcome and patient status are unknown.Concomitant device: distal locking screws (part unknown, lot unknown, quantity unknown), screws (part unknown, lot unknown, quantity unknown); tfna fenestrated helical blade (part 04.038.395, lot unknown, quantity unknown).This report is for one (1) lcp plate.This is report 2 of 2 for (b)(4).

• Brand Name: LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 7 HOLES/81MM
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8659273
• Report Number: 2939274-2019-58408
• Device Sequence Number: 16616699
• Product Code: HRS
• UDI-Device Identifier: 10886982166890
• UDI-Public: (01)10886982166890
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K011335
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/02/2019

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: 241.371
• Device Catalogue Number: 241.371
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 05/31/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TFNA FENESTRATED HELICAL BLADE 95MM; UNK - SCREWS: NAIL DISTAL LOCKING; UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention