MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM/3.5MM VA-LCP EXT MEDL DSTL HUM PL 6H/RT/137MM-XLNG; PLATE,FIXATION,BONE

Model Number	02.117.606
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional device product code: hwc.(b)(4).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review could not be completed without lot number.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 (b)(6) 2018, patient was implanted with one (1) posterolateral distal humerus plate, one (1) medium extended medial distal humerus plate and one (1) extra long extended medial distal humerus plate.Post operative, on (b)(6) 2018, patient underwent revision surgery due to a broken extra long extended medial distal humerus plate.Patient was revised to a longer plate of same type.All plates were explanted during surgery.There was no surgical delay.The procedure was completed successfully with patient outcome as satisfactory.Concomitant devices: right, medium va lcp posterolateral distal humerus plate (part: 02.117.602, lot: unknown, quantity 1).Right, long va lcp posterolateral distal humerus plate (part: 02.117.207, lot: unknown, quantity: 1).This report is for one (1) extra long extended medial distal humerus plate.This is report 1 of 1 for (b)(4).

• Brand Name: 2.7MM/3.5MM VA-LCP EXT MEDL DSTL HUM PL 6H/RT/137MM-XLNG
• 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: 7942912
• Report Number: 2939274-2018-54219
• Device Sequence Number: 941607
• Product Code: HRS
• UDI-Device Identifier: 10886982037046
• UDI-Public: (01)10886982037046
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K120070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2018

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: 02.117.606
• Device Catalogue Number: 02.117.606
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 10/08/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 109