MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM/3.5MM VA-LCP MEDL DSTL HUMERUS PL 4H/RT/108MM-LONG; PLATE, FIXATION, BONE

Model Number	02.117.404
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This information is unknown.Date of plate breakage is an unknown date in (b)(6) 2018.Lot number is unknown.Date of implantation is unknown date in (b)(6) 2017.Complainant part is not expected to be returned for manufacturer review/investigation.Date of concomitant therapy is the same date as date of implantation; unknown date in (b)(6) 2017.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 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.(b)(4).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 the patient was implanted with one (1) variable angle-locking compression plate medial distal humerus plate 4 holes and one (1) va-lcp medial distal humerus plate 5 holes on an unknown date in (b)(6) 2017.The patient fell on an unknown date in (b)(6) 2018 and broke the va-lcp medial distal humerus plate 4 holes.On (b)(6) 2018, the patient underwent a hardware removal and revision.The surgeon removed both plates and replaced them with the same kind of plate but two (2) holes longer.The procedure was completed successfully with no surgical delay.There was no patient consequence.Concomitant device reported: va-lcp medial distal humerus plate 5 holes (part: unknown, lot: unknown, quantity: 1), trauma device (part: unknown, lot unknown, quantity: unknown).This report is for a 2.7mm/3.5mm va-lcp medl dstl humerus pl 4h/rt/108mm-long.This is report 1 of 1 for (b)(4).

• Brand Name: 2.7MM/3.5MM VA-LCP MEDL DSTL HUMERUS PL 4H/RT/108MM-LONG
• 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: 7664708
• Report Number: 2939274-2018-52720
• Device Sequence Number: 1524701
• Product Code: HRS
• UDI-Device Identifier: 10886982036568
• UDI-Public: (01)10886982036568
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K120070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/11/2018

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: 02.117.404
• Device Catalogue Number: 02.117.404
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/11/2018
• Initial Report FDA Received Date: 07/05/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: THERAPY DATE: (B)(6) 2017
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR