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

Catalog Number 03.501.080

Device Problems Sticking (1597); Mechanical Jam (2983)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

No patient involvement.Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A service history review was performed ¿ service history review: part no: 03.501.080, lot no: 8572592.No service history review can be performed as this is a lot controlled item.The manufacture date of this item is 5-sep-2013.The source of the manufacture date is the release to warehouse date.The service history evaluation is unconfirmed.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 when the application instrument for sternal zipfix was fully depressed it would stick.Event found during testing, no surgery or patient involved.There is no additional information at this time.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

A service and repair evaluation was preformed: the customer reported the item was sticking when fully depressed.The repair technician reported binding as the reason for repair.The item is not repairable.The cause of the issue is unknown.This item was forwarded to the complaint handling unit on (b)(4) 2015.The evaluation was confirmed.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

A product investigation was completed: one application instrument for sternal zipfix (part number 03.501.080, lot number 8572592) was received with the complaint that when the device is fully depressed it sticks.It was reported to have been found during testing with no surgery involved.The complaint condition is confirmed as when the trigger is released from the retracted position it sticks and does not slide smoothly back to the resting state.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.While the root cause cannot be definitively determined, review of the failure mode determined that it is most probable that not properly maintaining the device as indicated in the technique guide resulted to the complaint condition.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.When the cutting mechanism is locked and the trigger is depressed, the trigger can be fully retracted.Then, when the trigger is released from the fully retracted position it sticks and does not slide smoothly back to the resting state.Thus, the complaint condition is confirmed, consistent with the reported condition, and can be replicated.The remaining functionality was tested and no further issues were determined.A review of the design drawing for the top level assembly was performed.The following component drawings were also reviewed; spring assembly, lever, small arm, pusher assembly, spacer, 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.Review of the failure mode determined that it is most probable that not properly maintaining the device as indicated in the technique guide resulted to the complaint condition.Specifically, it appears the binding is occurring between the spacer component and the pusher sleeve component where the tolerance is constrained to allow a sliding fit and to ensure proper alignment between the components.The technique guide provides specific instructions for lubricating the device prior to sterilization and includes this region as one of the three locations to apply oil.Furthermore, from handling of the device during investigation, the oil from the investigator¿s hand appears to have restored functionality.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: 5090872
• MDR Text Key: 26294176
• Report Number: 3003875359-2015-10405
• 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: Followup,Followup
• Report Date: 09/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Service and Testing Personnel
• Device Catalogue Number: 03.501.080
• Device Lot Number: 8572592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2013
• 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