MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM/3.5MM VA-LCP POSTLAT DSTL HUM PL 9H/LT/153MM-XLNG; PLATE,FIXATION,BONE

Model Number	02.117.309
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.(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 on an unknown date the patient underwent a revision surgery of the variable angle (va) locking compression plate (lcp) distal humerus plate and unknown screws in the distal humerus due to a re-fracture after the initial implant.The patient fell after the initial surgery causing a new fracture.All original implants were unbroken and removed successfully and completely.The devices were replaced with new synthes variable angle (va) medial distal humerus plate with screws and synthes 3.5 locking compression plate (lcp) recon plate with screws.This report is for one 2.7mm/3.5mm va-lcp postlat dstl hum pl 9h/lt/153mm-xlng.This is report 1 of 2 for (b)(4).

• Brand Name: 2.7MM/3.5MM VA-LCP POSTLAT DSTL HUM PL 9H/LT/153MM-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: 9740903
• Report Number: 2939274-2020-00991
• Device Sequence Number: 2179887
• Product Code: HRS
• UDI-Device Identifier: 10886982036421
• UDI-Public: (01)10886982036421
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K120717
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/31/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 02.117.309
• Device Catalogue Number: 02.117.309
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 02/21/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention