MAUDE Adverse Event Report: SYNTHES RARON 3.5MM LCP® PROXIMAL HUMERUS PLATE-STANDARD 5H SHAFT/114MM; APPLIANCE, FIXATION, NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT

Catalog Number 241.903

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Irritation (1941); Pain (1994); Discomfort (2330); Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Manufacturing location: (b)(4).Manufacturing date: february 17, 2014.No non-conformance reports 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.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 Description

It is reported patient underwent a procedure on (b)(6) 2015 to implant a locking compression plate (lcp) proximal humerus plate, seven (7) locking screws, and three (3) cortex screws to repair a right proximal humerus fracture.During a follow up examination with x-rays on an unknown date, it was determined patient had a non-union at the fracture site; it was reported the patient also experienced pain, irritation or discomfort.Patient was returned to surgery on (b)(6) 2016 where surgeon removed all hardware.It is reported all explanted hardware was intact.Patient was revised to a longer lcp proximal humerus plate, four (4) 3.5mm cortex screws, and eight (8) 3.5mm locking screws.The patient outcome/status was reported as fine.This complaint is linked to (b)(4) to address that it was also reported that a reduction forceps broke during this revision procedure.This is report 1 of 3 for (b)(4).

• Brand Name: 3.5MM LCP® PROXIMAL HUMERUS PLATE-STANDARD 5H SHAFT/114MM
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT
• Manufacturer (Section D): SYNTHES RARON; kanalstrasse west 30; raron CH394 2; SZ CH3942
• Manufacturer (Section G): SYNTHES RARON; kanalstrasse west 30; raron CH394 2; SZ CH3942
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5531429
• MDR Text Key: 41332409
• Report Number: 3006126083-2016-10015
• Device Sequence Number: 1
• Product Code: KTW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK011815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 241.903
• Device Lot Number: 8803003
• Other Device ID Number: (01)10886982167637(10)8803003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 54