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

Model Number 241.901

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

Patient Problem No Code Available (3191)

Event Type  Injury  

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.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(b)(4).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 was reported that during a revision procedure on an unknown date, a locking compression plate (lcp) proximal humerus plate, two (2) cortex screws, and six (6) locking screws were removed due to impingement of the plate.The screw sizes are unknown due to the plate being implanted at another facility.Procedure outcome and patient status are unknown.This report is for a 3.5mm lcp® proximal humerus plate.This is report 1 of 3 for (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): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK RARON (CH); kanalstrasse west 30; raron 3942 ; SZ 3942
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8200139
• MDR Text Key: 131532707
• Report Number: 2939274-2018-55607
• Device Sequence Number: 1
• Product Code: KTW
• UDI-Device Identifier: 10886982167620
• UDI-Public: (01)10886982167620
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 241.901
• Device Catalogue Number: 241.901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 103