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 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 service history review was attempted: no service history review can be performed as part number 03.501.080 with lot number(s) 8735246 is a lot/batch controlled item.The manufacture date of this item is 11-dec-2013.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed.Please launch a device history record review (dhr).Device history records was conducted.The report indicates that the: manufacturing location: (b)(4), manufacturing date: 05.Dec.2013, part #-03.501.080 lot #-8735246.No ncrs was 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.A service history evaluation/review was performed.The investigation of the complaint articles has shown that: the customer reported the zipfix gun was not tensioning very well.The repair technician reported the retaining nut was loose, both screws at the cutting end of the device were loose, and the device lacked proper oiling.Loose component is the reason for repair.The cause of the issue is unknown.No parts were replaced.The item was repaired per the inspection sheet, passed synthes final inspection on 4-may-2016 the component was repaired and tested to operational specifications and returned to the customer.No cause was observed; no manufacturing or design issues were noted.No corrective action is required at this time.The evaluation was confirmed.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 during a cabg surgery (coronary artery bypass graft), performed on an unknown date, one of the zip fix application guns was noted not to be working well.It was clarified that the device was not tensioning very well.The reporter stated that the sterile processing department informed him of the product malfunction on (b)(6) 2016 and that the surgeon is on vacation, so he was unable to get an update.It was reported that the surgeon had another hand piece (zip fix gun was readily available in the room) and that the back-up device was used to complete the surgery.There was no disruption, no additional medical invention, and no harm to the patient.There was a very minimal delay of less than one minute.The patient status was noted to be stable at the end of surgery.This complaint has 1 device.This report is 1 of 1 for (b)(4).

• 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: 5670455
• MDR Text Key: 45635905
• Report Number: 3003875359-2016-10312
• 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: Other
• Type of Report: Initial
• Report Date: 04/21/2016

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: 8735246
• Other Device ID Number: (01)10887587010847(10)8735246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/21/2016
• Initial Date FDA Received: 05/20/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/05/2013
• 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