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

Catalog Number 03.501.080

Device Problems Detachment of Device or Device Component (2907); Mechanical Jam (2983)

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

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.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 subject device has been received and is currently in the evaluation process.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 zipfix tensioner is broken.The screw that holds the spring in place on the back has come undone (is loose) resulting in the device not operating correctly and the trigger couldn't be pulled back.There was no reported surgical delay or adverse effect on the procedure or patient.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

A product investigation was completed: one application instrument for sternal zipfix (part number 03.501.080, lot number 8215969) was received with the complaint that the screw that holds the spring in place on the back has come undone.The complaint condition is confirmed as the end cap and spring were found to be loose and could be disassembled by hand.A review of the current design drawing/manufactured revision for the top level assembly was performed.The following component drawings were also reviewed; pusher assembly, end cap component, and pusher sleeve component.During the design review it was determined that there was a change to revise the pusher assembly in may 2013 to add that the end cap is to be secured.The change was made after the manufacture date of the received device.Thus, the design likely impacted to complaint condition.No additional issues or discrepancies were observed and the current design was determined to be suitable for the intended use when employed and maintained as recommended.Per the technique guide, this device is part of the sternal zipfix system and it is used to tension and cut the zipfix implants.Proper use and maintenance is addressed in technique guide.The returned device was received intact with a few scratches on the surface of the device.The end cap, which retains the spring, was found to be loose and could be disassembled by hand.Thus, the complaint condition is confirmed, consistent with the reported condition, and can be replicated as the spring is not retained as intended.The remaining functionality was tested and no further issues were determined.When the cutting mechanism is locked, the trigger compresses and releases as intended and all components move fully through their range of motion.When the cutting mechanism is unlocked, the lever arm functions as intended and the trigger is locked as intended so that the device would not cut with the implant under tension.Thus, the complaint condition was possibly a result of a design deficiency that has been addressed.No additional issues or discrepancies were observed and the current design was determined to be suitable for the intended use when employed and maintained as recommended.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.

• 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5185361
• MDR Text Key: 29799831
• Report Number: 3003875359-2015-10446
• 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: 10/13/2015

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: 8215969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2015
• Initial Date FDA Received: 10/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2013
• 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