MAUDE Adverse Event Report: SYNTHES HAGENDORF APPLICATION INSTRUMENT FOR STERNAL ZIPFIX; CERCLAGE FIXATION

Model Number 03.501.080

Device Problems Failure To Adhere Or Bond (1031); Device Operates Differently Than Expected (2913)

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

Event Date 08/21/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided for reporting.Device is an instrument and is not implanted / explanted.No service history review can be performed as part number 03.501.080 with lot number(s) 8735273 is a lot/batch controlled item.The manufacture date of this item is 10-jan-2014.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed.Device history records review was completed for part# 03.501.080, lot# 8735273.Manufacturing location: (b)(4), manufacturing date: jan 04, 2014.No non-conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The device was received and the product evaluation is in progress.No conclusion can be drawn.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 service and repair department documented as follows: the customer reported that two (2) application instruments for sternal zipfix would not cinch during a procedure on (b)(6) 2017.Patient was undergoing procedure for coronary artery bypass grafting (cabg).There was no patient injury and a third application instrument for sternal zipfix was used to complete the procedure.Procedure was completed successfully with approximately 5-10 minutes of delay.Patient outcome was reported as good.This report is for one (1) application instrument for sternal zipfix.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Device history records review was completed for part# 03.501.080, lot# 8735273.Manufacturing location: (b)(4), manufacturing date: jan 07, 2014.No non-conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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.

Manufacturer Narrative

The service and repair evaluation is as follows: the customer reported the device would not cinch.The repair technician reported the handle/trigger was sticking, and the torque retaining nut was loose.Sticky trigger is the reason for repair.The cause of the issue is unknown.No parts were replaced.The item was repaired per the inspection sheet, passed synthes final inspection on 22-sep-2017 and will be returned to the customer upon completion of the service and repair process.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: APPLICATION INSTRUMENT FOR STERNAL ZIPFIX
• Type of Device: CERCLAGE FIXATION
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6866525
• MDR Text Key: 86444643
• Report Number: 3003875359-2017-10456
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 10887587010847
• UDI-Public: (01)10887587010847(10)8735273
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/21/2017

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
• Device Model Number: 03.501.080
• Device Catalogue Number: 03.501.080
• Device Lot Number: 8735273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/22/2017
• Initial Date FDA Received: 09/14/2017
• Supplement Dates Manufacturer Received: 09/18/2017; 09/26/2017
• Supplement Dates FDA Received: 09/19/2017; 10/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1