MAUDE Adverse Event Report: SYNTHES USA; CERCLAGE FIXATION

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Code Available (3191)

Event Date 07/01/2015

Event Type  Injury  

Event Description

It was reported that the surgeon was closing the sternum after completing an aortic valve replacement.A combination of wires and two (2) zip fix cables were placed.One of the zipfix cables failed during tightening with the wires.The surgeon says a cable came loose after the wires and cables were cut (following tightening).The sharp edge fell down inside the chest cavity of the patient.Both zipfix cables were removed.The chest was reopened and all wires were placed.A delay of approximately five (5) minutes was reported.This report is for one (1) unknown zipfix cable.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: additional patient information: patient height was reported as (b)(6).Patient identifier is not available for reporting.This report is for one (1) unknown zipfix cable.Event occurred intra-operatively.The device was not implanted or explanted.Additional medical intervention required for the zipfix to be re-opened and removed.Unknown, as specific part and lot numbers for the complainant zipfix cable were not provided.Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.Device 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: CERCLAGE FIXATION
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4906084
• MDR Text Key: 6830960
• Report Number: 2520274-2015-14879
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 113