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.Service & repair evaluation: the customer reported that the item would not cinch down; the repair technician reported that the item was not moving properly with minor damages and visible signs of metal-on-metal rubbing.Binding is the reason for repair, but the item is not repairable (per the inspection sheet).The cause of the issue is unknown.The item will be forwarded for further investigation and evaluation.Service history record review: no service history review can be performed as part number 03.501.080 with lot number 8497301 is a lot/batch controlled item.The release to warehouse date was august 7, 2013.The service history review is unconfirmed.Device history record review: manufacturing location: (b)(4) - manufacturing date: august 2, 2013.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 an application instrument for sternal zipfix would not cinch down, which would prevent the device from tightening a zipfix implant.The malfunction was discovered during sterile processing, with no known patient or procedural involvement.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Product investigation summary: one (1) application instrument for sternal zipfix was received with the complaint category of ¿does not/will not function: will not tension/tighten.¿ a device history record (dhr) review, visual inspection, functional test, and drawing review were performed as part of this investigation.The complaint condition was confirmed as the condition could be replicated.The pusher assembly and spring were found to be immobile and wear marks on the right inside panel were observed.The complaint condition is consistent with binding of the device.However, the root cause of the binding could not be definitively determined given the unknown care and maintenance of the device.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.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 intact with surface wear and small nicks along the edges of the device.During the service and repair evaluation, the condition was replicated.The remaining functionality was tested and no further issues were determined.A review of the current design drawing for the assembly was performed.The following component drawings were also reviewed; spring assembly, pusher assembly, and pusher sleeve.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.The sternal zipfix system technique guide provides instruction on the care and maintenance of this device and provides specific instructions for lubricating the device prior to sterilization to ensure smooth function.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.

• 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: 5703476
• MDR Text Key: 46709591
• Report Number: 3003875359-2016-10333
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK110789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/19/2016

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: 8497301
• Other Device ID Number: (01)10887587010847(10)8497301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2016
• Initial Date FDA Received: 06/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2013
• 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