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 Device-Device Incompatibility (2919)

Patient Problems Impaired Healing (2378); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).A device history record (dhr) review was conducted: part: 241.901.Lot: 9880299.Manufacturing site: (b)(4).Release to warehouse date: (b)(6) 2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.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 on (b)(6) 2020, the patient underwent a removal of the proximal humerus plate and revision of the proximal humerus fracture with ria bone graft.Originally, the patient was implanted of plate and screws on (b)(6) 2020.The revision procedure was performed due to one locking screw that backed out of the head of the plate and malreduced the fracture.During the revision procedure the original implants were removed and the patient was revised with plate and bone graft.The procedure was successfully completed.Patient status was good.Concomitant device reported: locking screws (part # unknown, lot # unknown, quantity 10), cortex screw (part # unknown, lot # unknown, quantity 1).This report is for 1 3.5mm lcp® proximal humerus plate-standard 3h shaft/90mm.This is report 1 of 2 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: 10299190
• MDR Text Key: 199666750
• Report Number: 2939274-2020-03263
• 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: Physician
• Type of Report: Initial
• Report Date: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 241.901
• Device Catalogue Number: 241.901
• Device Lot Number: 9880299
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 117