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U.S. Department of Health and Human Services

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

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC SYNFIX® EVOLUTION AWL/WITHOUT SLEEVE Back to Search Results
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).

 
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Brand NameSYNFIX® EVOLUTION AWL/WITHOUT SLEEVE
Type of DeviceAWL
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
SYNTHES HAEGENDORF GMBH-CN
im bifang 6
haegendorf 4614
SZ 4614
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key8591934
MDR Text Key145774510
Report Number2939274-2019-57894
Device Sequence Number1
Product Code HWJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/09/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/08/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number03.835.032
Device Catalogue Number03.835.032
Device LOT NumberEV24591
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/06/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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