MAUDE Adverse Event Report: SYNTHES RARON 3.5MM LCP RECONSTRUCTION PLATE10 HOLES/140MM; APPLIANCE,FIXATION,NAIL

Model Number	245.101
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Device is not expected to be returned for manufacturer review/investigation.(b)(4).Device history records review was conducted.The report indicates that the: part 245.101.Lot 7804554.Manufacturing location: (b)(4).Manufacturing date: 07.Mar.2012.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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 proximal ulna revision was performed due to a broken plate and nonunion on (b)(6) 2017.The original right sided ulna repair was performed on (b)(6) 2017.On an unknown date post-operatively, it was discovered that the plate had broken and the fracture was in nonunion.Removed hardware included: one ten-hole locking compression (lcp) recon plate (broken in the middle over a screw hole), three cortex screws (intact) and five locking screws (intact).During the revision procedure, the fracture was opened, irrigated, and re-plated.Cultures were taken to rule out infection.No infection was found.The patient was revised to an eight-hole olecranon plate and screws.There was no additional medical intervention or surgical delay reported.The revision was completed successfully with the patient in stable condition.This complaint involves 1 device concomitant devices: unknown cortex screw (partial part# , lot unknown, qty 3).Unknown locking screw (partial part#, lot unknown, qty 5).This report is 1 of 1 for (b)(4).

• Brand Name: 3.5MM LCP RECONSTRUCTION PLATE10 HOLES/140MM
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): SYNTHES RARON; kanalstrasse west 30; raron CH394 2; SZ CH3942
• MDR Report Key: 7015982
• Report Number: 3006126083-2017-10049
• Device Sequence Number: 1197131
• Product Code: KTT
• UDI-Device Identifier: 10886982169655
• UDI-Public: (01)10886982169655(10)7804554
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K000684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/17/2017

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 245.101
• Device Catalogue Number: 245.101
• Device Lot Number: 7804554
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2017
• Initial Report FDA Received Date: 11/09/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Weight: 82