MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP® MEDIAL DISTAL HUMERUS PLATE 5 HOLES-RIGHT; APPLIANCE,FIXATION,NAIL

Model Number	241.284
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Not Applicable (3189)
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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 patient previously sustained an injury to his left arm and underwent a fixation of the supracondylar humerus fracture on an unspecified date.The patient reports subsequent loosening of this hardware.Patient is now several years out from this procedure and has pain and dysfunction with difficulty lifting on that side.X-rays revealed evidence of a non-union with gross motion to the fracture site, surgical intervention for the correction of the non-union was performed on (b)(6) 2015.Patient was returned to surgery on (b)(6) 2016 for repair of a nonunion left supracondylar humeral fracture was performed using products manufactured by depuy and medtronic.It is unknown if the devices used in original procedure were synthes or non synthes devices.During this procedure, the failed hardware was removed which included a plate that was found to be broken, along with an unspecified amount of broken and failed screws.Patient was again returned to surgery on (b)(6) 2016 where surgeon performed a correction of a non-union of left supracondylar humerus fracture.Depuy synthes hardware was explanted and bone graft was implanted.Surgeon also performed neurolysis of the left ulnar nerve.The revision procedure on (b)(6) 2015 is addressed in (b)(4).The revision procedure on (b)(6) 2016 is addressed in (b)(4).This report captures the revision on (b)(6) 2016.This report is for one (1) 3.5mm lcp medial distal humerus plate this is report 3 of 6 for (b)(4).

• Brand Name: 3.5MM LCP® MEDIAL DISTAL HUMERUS PLATE 5 HOLES-RIGHT
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7774857
• Report Number: 2939274-2018-53285
• Device Sequence Number: 16423632
• Product Code: KTT
• UDI-Device Identifier: 10886982166555
• UDI-Public: (01)10886982166555
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K033995
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/05/2018

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: 241.284
• Device Catalogue Number: 241.284
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2018
• Initial Report FDA Received Date: 08/10/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention