MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC COUPLING FOR SYNFIX® EVOLUTION AIMING DEVICE HOLDER; IMPACTOR

Model Number	03.835.005
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that on an unknown date, the synfix evolution aiming device holder was jammed with the coupling for aiming device holder synfix evolution.The issue was discovered at the sterile processing department.There were no patient and surgical involvement.Concomitant device reported: synfix® evolution aiming device holder (part# 03.835.004, lot# 4l26073, quantity 1).This is report 2 of 2 for (b)(4).
Additional 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.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is company representative.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: COUPLING FOR SYNFIX® EVOLUTION AIMING DEVICE HOLDER
• Common Device Name: IMPACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9842919
• Report Number: 2939274-2020-01308
• Device Sequence Number: 16861932
• Product Code: HWA
• UDI-Device Identifier: 10705034814124
• UDI-Public: (01)10705034814124
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2020

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
• Operator of Device: Health Professional
• Device Model Number: 03.835.005
• Device Catalogue Number: 03.835.005
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 04/09/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 04/09/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SYNFIX® EVO AIM DEV HOLD