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

Catalog Number 03.501.080

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 06/23/2016

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted or explanted.The complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Investigation could not be completed and no conclusion could be drawn as no device was returned.A review of the service history records has been requested and is currently pending completion.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.

Event Description

It was reported that a patient underwent open heart surgery on (b)(6) 2016.As the surgeon was attempting to use an application instrument for sternal zipfix, it was noted that the device would not tighten.Instead, the device kept slipping.As a result, the use of a readily available, alternate device was employed.The procedure was completed successfully without reported delay or patient harm.The patient's post-operative status was reported to be stable.This report is 1 of 1 for com-(b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A service history record review was attempted for the subject device but could not be completed because the device is a lot/batch controlled item.A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.The date of manufacture is dec 9, 2011.A service and repair evaluation was also completed for the subject device.The customer reported the device would not tighten and kept slipping.The repair technician reported the adjustment nut (end cap) was loose.¿loose component¿ is the reason for repair.The subject device is not repairable per the inspection sheet.The cause of the issue is unknown.The service and repair evaluation was confirmed.The subject device will be forwarded to synthes customer quality for additional investigation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.A product development investigation was performed for the subject device (application instrument for sternal zipfix, part number 03.501.080, lot number 7689244).The subject device was received with the complaint category of ¿does not/will not function: will not tension/tighten.¿ this device is part of the sternal zipfix system and used to tension and cut the sternal zipfix implants.Proper use and maintenance is addressed in technique guide.The device was received with the end cap, which retains the spring, loose.The end cap could be disassembled by hand.Residue, likely related to maintenance, was observed on the inner surfaces of the device.The device was functionally tested and when the trigger was released from the fully retracted position it sticks slightly just before returning to the resting state.Thus, the complaint condition is confirmed, consistent with the reported condition, and can be replicated.No further functional issues were observed.A review of the current drawing and history for the top level assembly was performed.The following component drawings were also reviewed; spring assembly and pusher assembly, end cap component, and pusher sleeve component.The following items were determined; this lot number is included in additional action which was initiated because when using the 1st generation instrument it is possible to cut the implant while the tensioning trigger is being squeezed which could lead to loosening of the implant.This issue has been addressed and is found to be unrelated to the compliant condition.The pusher assembly document was revised in may, 2013 to add that the end cap is to be secured.This change was made after the manufacture date of the received device.Furthermore, this lot is part of additional actions which have been implemented to address instruments manufactured prior to this change document.Thus, the condition of a loose end cap was likely a result of design deficiencies that have been addressed.No unaddressed issues or discrepancies relating to the complaint condition were observed.The root cause is related to this finding.With regard to the trigger sticking the following was noted: review of the failure mode and discussion with the product development subject matter expert determined that the tensioning issue is consistent with the result of not properly maintaining the device as indicated in the technique guide.Specifically, it appears binding may be occurring between the spacer component and the pusher sleeve component when the device is not adequately lubricated as this is where the tolerance is tightly constrained to allow a sliding fit and to ensure proper alignment between the components.The sternal zipfix system technique guide provides instruction on the care and maintenance of this device.It provides instructions for lubricating the device prior to sterilization and includes this location as one of the three specific locations to oil directly.As the details regarding the use and maintenance of this device are unknown a root cause cannot be definitively determined for this portion of the complaint.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: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5778763
• MDR Text Key: 49060884
• Report Number: 3003875359-2016-10404
• Device Sequence Number: 1
• Product Code: JDQ
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 06/24/2016

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
• Device Catalogue Number: 03.501.080
• Device Lot Number: 7689244
• Other Device ID Number: (01)10887587010847(10)7689244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/24/2016
• Initial Date FDA Received: 07/08/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/28/2016; 08/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-2475-2015
• Patient Sequence Number: 1