MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LOCK/NEUTRAL GUIDE F/4.5MM VA LCP CRVD CONDYLAR AIMING ARM; SCREW,FIXATION,BONE

Model Number 03.231.007

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Without a lot number the device history records review could not be completed.Product was not returned.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

Device report from synthes reports an event in (b)(4) as follows: it was reported that on an unknown date, the trocar wouldn't clip in locking/neutral guide for the 4.5mm curved condylar plate aiming arm.No more information is available.Concomitant devices reported: unknown guides/sleeves/aiming: aiming arm (part# unknown, lot# unknown, quantity# 1) unknown plate (part# unknown, lot# unknown, quantity# 1).This report is for one (1) lock/neutral guide f/4.5mm va lcp crvd condylar aiming arm.This is report 2 of 2 for (b)(4).

Event Description

This is report 1 of 1 for (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.Updated data-b5.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.

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.H10 additional narrative: h3, h4, h6: 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.

• Brand Name: LOCK/NEUTRAL GUIDE F/4.5MM VA LCP CRVD CONDYLAR AIMING ARM
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9612852
• MDR Text Key: 190489387
• Report Number: 2939274-2020-00304
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886982077349
• UDI-Public: (01)10886982077349
• Combination Product (y/n): N
• PMA/PMN Number: K110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.231.007
• Device Catalogue Number: 03.231.007
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/28/2019
• Initial Date FDA Received: 01/21/2020
• Supplement Dates Manufacturer Received: 02/05/2020; 03/16/2020
• Supplement Dates FDA Received: 02/17/2020; 03/16/2020
• Patient Sequence Number: 1
• Treatment: UNK - GUIDES/SLEEVES/AIMING: AIMING ARM; UNK - PLATES