MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; WIRE, SURGICAL

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2019

Event Type  malfunction  

Manufacturer Narrative

This report is for an unknown cable/unknown lot.Part and lot number are unknown; udi number is unknown.Reporter is a synthes employee.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 during open reduction internal fixation (orif) of a femur (b)(6) 2019, the cable was stuck inside the cable tensioner and the tip was missing.The remaining part of the cable that was cut and would normally be discarded could not be removed from the tensioner as the tensioner would not loosen and is stuck.It was further reported that cable was tensioned, crimped and cut and surgical use of the cable was completed as normal.Procedure was successfully completed.Patient status is unknown.This report is for an unknown cable.This is report 2 of 2 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.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.H3, h6: the device was first received by synthes service and repair.The service and repair evaluation determined the following: the customer reported that a cable was stuck inside the device and the device tip was missing.The repair technician reported the device was missing some components and there was a cable stuck inside.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item was then forwarded to customer quality, then to the supplier/manufacturer for further investigation.Visual inspection and functional testing sections below were performed by the manufacturer/supplier.Visual inspection was performed by the manufacturer confirmed the tensioner is missing the nose piece.The cable could not be removed from the collet jaws due to the missing component of the tensioner.The nose piece is required to remove a cable.The complaint of a stuck cable and missing nose piece were confirmed with investigation.No issues with the cable were noted.The device interaction/functional issue was the result of a missing component on the tensioner.There were no issues during the manufacture of this product that would contribute to this complaint condition.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.The stuck cable was attributed to the missing nose piece.A root cause of the missing nose piece could not be determined with investigation, however, it is likely the removable component was misplaced during handling.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.

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.H3, h4, h6- legal manufacturer (rti surgical) is aware and the issue was identified by rti surgical during the service activity.This event has been logged in their system under (b)(4) on (b)(6) 2019.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.

• 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: 8588463
• MDR Text Key: 145740693
• Report Number: 2939274-2019-57887
• Device Sequence Number: 1
• Product Code: LRN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 04/09/2019

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Initial Date Manufacturer Received: 04/09/2019
• Initial Date FDA Received: 05/07/2019
• Supplement Dates Manufacturer Received: 06/06/2019; 01/09/2020
• Supplement Dates FDA Received: 06/06/2019; 01/13/2020
• Patient Sequence Number: 1