MAUDE Adverse Event Report: SYNTHES USA; CERCLAGE FIXATION

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

This report is for an unknown zipfix implant/unknown lot.Part and lot number are unknown; udi number is unknown.Due to intra-operative issues, the device was not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 during a coronary bypass procedure the application instrument for sternal zipfix did not release and the implant would get stuck and could not be tensioned.Scissors had to be used to cut the zipfix implant.There is no report of patient harm or surgical delay.This report is for an unknown zipfix implant.This is report 2 of 2 for (b)(4).

• Type of Device: CERCLAGE FIXATION
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6213528
• MDR Text Key: 63626520
• Report Number: 2520274-2016-15799
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/05/2016

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?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/05/2016
• Initial Date FDA Received: 12/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1