MAUDE Adverse Event Report: SYNTHES RARON 3.5MM LCP® PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM; APPLIANCE, FIXATION, NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT

Catalog Number 241.901

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

Patient Problems Pain (1994); Fracture, Arm (2351)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.The subject device is not expected to be returned to the synthes manufacturer for evaluation and was reportedly disposed of by the hospital.A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the patient underwent revision surgery on (b)(6) 2016 to treat a humeral fracture located distally to a previously implanted 3.5mm locking compression plate (lcp) 90mm, three cortex screws and nine locking screws.It is unknown when the original hardware was implanted.It was reported that the patient was traveling on an unknown date and experienced pain when reaching.It is not known when the fracture occurred.During the (b)(6) 2016 revision surgery, the existing hardware was noted to be intact.The 3.5mm lcp humerus plate 90mm and two cortex screws were removed.The patient was revised to a longer 3.5mm lcp 196mm and the one of the original cortex screws and the nine original locking screws were re-implanted.The surgery was successfully completed without delay.This report is 1 of 3 for com-(b)(4).

• Brand Name: 3.5MM LCP® PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM
• 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: 5612378
• MDR Text Key: 43802526
• Report Number: 3006126083-2016-10019
• 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: Health Professional
• Type of Report: Initial
• Report Date: 04/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 241.901
• Device Lot Number: 9570747
• Other Device ID Number: (01)10886982167620(10)9570747
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR