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

Catalog Number 03.501.080

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

This device was used for treatment, not diagnosis.(b)(4).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.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No service history review can be performed as part number 03.501.080 with lot number(s) 7738573 is a lot/batch controlled item.The manufacture date of this item is 24-jan-2012.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed.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 the service and repair department documented that the trigger for the application instrument for sternal zipfix was not functioning properly and a screw was missing.The issue was found while checking the device and there was no surgery or patient involvement.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

A service and repair evaluation was completed: the customer reported the trigger was not working properly, and a screw was missing.The repair technician reported the device was missing multiple screws, the retaining nut was loose, and the device would not advance properly.Missing parts is the reason for repair.The repair technician attempted to repair the device with new screws, but during the repair it was discovered that the internal spacer was missing.The internal spacer is not on the bill of material, so the item could not be repaired.The cause of the issue is unknown.The item will be forwarded to customer quality.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

Device was used for treatment, not diagnosis.A product development investigation was performed for the subject devices.The service and repair department documented that the trigger for the application instrument for sternal zipfix was not functioning properly and a screw was missing.The issue was found while checking the device and there was no surgery or patient involvement.The returned application instrument for sternal zipfix (03.501.080, 7738573) was received disassembled, but all critical parts were returned and a screw did not appear to be missing as stated in the complaint description, therefore the complaint condition was unconfirmed.As part of this investigation a visual inspection, drawing review, root cause analysis, and risk management assessment were performed.Based on the available information it is not possible to determine a definitive root cause, but it was determined that design changes implemented after the subject instrument was manufactured will help prevent similar complaint conditions in the future.Upon receipt of the instrument and its loose parts, they were able to be reassembled, and the instrument was found to function as intended.It is possible that the returned instrument was unnecessarily disassembled during sterile processing and unable to be reassembled afterwards.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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5960744
• MDR Text Key: 55098707
• Report Number: 3003875359-2016-10497
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 09/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2016
• 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: 7738573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2012
• 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