MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.0MM KIRSCHNER WIRE W/TROCAR POINT 150MM; WIRE, SURGICAL

Model Number 292.20

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/19/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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 history lot: null.Device history batch: null.Device history review: null.

Event Description

It was reported that on (b)(6) 2019, the kirschner wire broke during extraction for provision fixation and it was left in the patient's femur.There was no surgical delay.The procedure was successfully completed.The patient outcome was unknown.Concomitant device reported: unknown humerus plate (part # unknown, lot # unknown, quantity # 1).This complaint involves one (1) device.This is 1 of 1 for report (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.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: 2.0MM KIRSCHNER WIRE W/TROCAR POINT 150MM
• Type of Device: WIRE, SURGICAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9437339
• MDR Text Key: 196421018
• Report Number: 2939274-2019-62550
• Device Sequence Number: 1
• Product Code: LRN
• UDI-Device Identifier: 20886982180411
• UDI-Public: (01)20886982180411
• Combination Product (y/n): N
• 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: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 292.20
• Device Catalogue Number: 292.20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/02/2020
• Patient Sequence Number: 1
• Treatment: UNK - PLATES
• Patient Age: 77 YR