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 Patient Involvement (2645)

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.Service history record review: no service history review can be performed as part: 03.501.080 / lot: 9742688 is a lot/batch controlled item.The release to warehouse date of this item was december 23, 2015.The service history review is unconfirmed.Device history record review: manufacturing location: (b)(4) - manufacturing date: december 18, 2015.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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 three (3) application instruments for sternal zipfix were found with trigger problems and bent fins during the sterilization process.At this time, it is unknown if the trigger issues and bent fins (which led to leaver movement and seating issues) affected all items or if it was one (1) identified malfunction per device.There was no reported patient or surgical involvement.This report is 1 of 3 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A service and repair evaluation was performed for the subject device (application instrument for sternal zipfix, part number 03.501.080, lot number 9742688).The customer reported the fins were bent and the trigger was having problems.The repair technician reported the lock for the cutting arm was bent.¿bent¿ 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 confirmed the complaint condition.The subject device was forwarded to synthes customer quality for additional investigation.A product development investigation was performed for the subject device.The device was received with bent leaf springs (bent upward).The device was functionally tested and the bent springs are causing a sticking/jamming condition and not allowing the device to function as intended.Thus, the complaint condition is confirmed, consistent with the reported condition, and can be replicated.No further functional issues were observed.While a root cause of the issue with the trigger could not be determined, review of the failure mode and discussion with the product development subject matter expert determined that it is consistent with the result of not properly maintaining the device as indicated in the technique guide.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 technique guide 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.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.No product design issues or discrepancies were observed.No unaddressed issues or discrepancies relating to the complaint condition were observed and the current designs were determined to be suitable for their intended use when employed and maintained as recommended.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: 5812964
• MDR Text Key: 50188306
• Report Number: 3003875359-2016-10422
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2016
• 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: 9742688
• Other Device ID Number: (01)10887587010847(10)9742688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1