MAUDE Adverse Event Report: SYNTHES RARON 3.5MM LCP® POSTEROLATERAL DSTLHUMERUS PL-LAT SUPPORT 7H-LT; APPLIANCE, FIXATION, NAIL

Catalog Number	241.277
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Impaired Healing (2378); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Device is not expected to be returned for manufacturer review/investigation.(b)(4).Device history records review was completed for part# 241.27, lot# 1970018.Manufacturing location: (b)(4), manufacturing date: aug 27, 2008.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.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 that a patient was implanted with four unknown synthes 3.5 cortex screws, eight unknown 2.7 mm val screws, six unknown 3.5 locking screws, a 7 hole 3.5 mm lcp posterolateral distal humerus plate, and a 6 hole extra long 2.7/3.5 mm va-lcp extended medial distal humerus plate to treat a left distal humerus fracture on an unknown date.On an unknown date postoperatively, it was identified that the patient had developed a non-union of the fracture.On (b)(6) 2017, the patient was returned to the operating room and all of the devices were removed easily and intact.The non-union was debrided and grafted and the patient was revised with longer plates.No delay in surgery was reported and no adverse events against the patient were identified.Procedure was completed successfully and patient outcome was reported as okay.This report is for one (1) 3.5 mm lcp posterolateral dstl humerus pl-lat support 7h-lt.This is report 1 of 5 for (b)(4).

• Brand Name: 3.5MM LCP® POSTEROLATERAL DSTLHUMERUS PL-LAT SUPPORT 7H-LT
• Common Device Name: APPLIANCE, FIXATION, NAIL
• Manufacturer (Section D): SYNTHES RARON; kanalstrasse west 30; raron CH394 2; SZ CH3942
• MDR Report Key: 6416942
• Report Number: 3006126083-2017-10013
• Device Sequence Number: 42615
• Product Code: KTT
• UDI-Device Identifier: 10886982166456
• UDI-Public: (01)10886982166456(10)1970018
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K033995
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/27/2017

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: Physician
• Device Catalogue Number: 241.277
• Device Lot Number: 1970018
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2017
• Initial Report FDA Received Date: 03/20/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 99