MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SYNFIX® EVOLUTION AWL/WITHOUT SLEEVE

Model Number 03.835.032

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Lot number for the entire set is ev24591.The lot number for individual part number is not available.Device is expected to be returned for manufacturer review/investigation, but has not been received yet.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 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 the synfix evolution set, standard instruments-eval was used in surgery on (b)(6) 2019.On (b)(6) 2019, field stocking location (fsl) was informed that the set was ready for pick up on that date.The screw loading station for synfix evolution, synfix evolution awl/without sleeve, handle with quick coupling-small, and two (2) synfix evolution screwdriver without thread lock sleeve was picked up by owens and minors.Upon inspection, qwens and minors found blood on the parts of the set and reported to fsl.It was further clarified that these are instrument trays used by fsal and the trays were discovered to be "soiled".There was no patient involvement.This report is for one (1) synfix evolution awl/without sleeve.This is report 2 of 5 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.Lot number provided as ev24591.The part/lot combination could not be verified, therefore no manufacturing record evaluation possible.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: SYNFIX® EVOLUTION AWL/WITHOUT SLEEVE
• Type of Device: AWL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8591934
• MDR Text Key: 145774510
• Report Number: 2939274-2019-57894
• Device Sequence Number: 1
• Product Code: HWJ
• UDI-Device Identifier: 10705034814179
• UDI-Public: (01)10705034814179
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.835.032
• Device Catalogue Number: 03.835.032
• Device Lot Number: EV24591
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1