MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM/3.5MM VA-LCP POSTLAT DSTL HUM PL 3H/RT/75MM-SHORT; PLATE,FIXATION,BONE

Model Number	02.117.203
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is unknown.Additional device product codes: hwc.Device is not expected to be returned for manufacturer review/investigation.(b)(4).Device history records review was completed for part# 02.117.203, lot# l134379.Manufacturing location: (b)(4), release to warehouse date: sep 16, 2016.No non- conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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) 2017, patient underwent surgery for an open reduction on internal fixation of the right humerus.On (b)(6) 2018, a hardware removal and revision surgery was performed due to a non-union.During the revision surgery, a 2.7 mm/3.5 mm va-lcp postlat and nine unknown screws were removed.All hardware was removed intact, no malfunctions.The revision surgery entailed an unknown synthes plate and unknown screws.The procedure was completed successfully without any delays and patient status was reported as satisfactory.This report is for one (1) 2.7 mm/3.5 mm va-lcp postlat dstl hum pl 3h/rt/75 mm-short.This is report 1 of 2 for (b)(4).

• Brand Name: 2.7MM/3.5MM VA-LCP POSTLAT DSTL HUM PL 3H/RT/75MM-SHORT
• 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: 7437420
• Report Number: 2939274-2018-51775
• Device Sequence Number: 13492601
• Product Code: HRS
• UDI-Device Identifier: 10886982036100
• UDI-Public: (01)10886982036100
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K120717
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/27/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 02.117.203
• Device Catalogue Number: 02.117.203
• Device Lot Number: L134379
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/27/2018
• Initial Report FDA Received Date: 04/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 29 YR
• Patient Weight: 82