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

Event Type  Injury  

Manufacturer Narrative

Patient id also reported as (b)(6).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 on (b)(6) 2019, the patient underwent revision open reduction internal fixation (orif) of the right proximal humerus due to nonunion.The following hardware was removed: one (1) locking compression plate (lcp) proximal humerus plate-standard 3h head shaft.One (1) cortex screw self-tapping 34mm.One (1) cortex screw self-tapping 30mm.Two (2) locking screw self-tapping with stardrive recess 52mm.One (1) locking screw self-tapping with stardrive (tm) recess 40mm.One (1) locking screw self-tapping with stardrive recess 48mm.One (1) locking screw self-tapping with stardrive (tm) recess 38mm.One (1) locking screw self-tapping with stardrive (tm) recess 50mm.One (1) locking screw self-tapping with stardrive recess 46mm.One (1) locking screw self-tapping with stardrive (tm) recess 32mm.Hardware was originally implanted on december 23, 2017.All hardware was removed successfully and intact.Procedure was successfully completed.Patient status is unknown.This report is for a 3.5mm lcp® proximal humerus plate.This is report 1 of 10 for (b)(4).Additional reports are captured under (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.

• 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
• MDR Report Key: 8491087
• MDR Text Key: 141180047
• Report Number: 2939274-2019-57334
• Device Sequence Number: 1
• Product Code: KTW
• UDI-Device Identifier: 10886982167620
• UDI-Public: (01)10886982167620
• Combination Product (y/n): N
• PMA/PMN Number: K011815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• 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
• Date Manufacturer Received: 03/14/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention