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 was used for treatment, not diagnosis.Additional narrative: the exact date of device issue is unknown; however, the issue was discovered in the operating room.Device is an instrument and is not implanted/explanted.Subject device has been received and is currently in the evaluation process.Part number: 03.501.080, synthes lot number: 8735273: release to warehouse date: jan 7, 2014.Mfg.Site: (b)(4).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 this product that would contribute to this complaint condition.A review of the service history records has been requested.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The service and repair department documented that the application instrument for sternal zipfix will not tighten.There was no patient involvement and no delay in surgery.The instrument was tested prior to the patient entering the operating room.An alternate instrument was available to complete the procedure.This is report number 1 of 1 for (b)(4).

Manufacturer Narrative

No service history review can be performed as part number 03.501.080 with lot number(s) 8735273 is a lot/batch controlled item.The manufacture date of this item is january 10, 2014.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed.A service and repair evaluation was completed: the customer reported the device would not tighten.The repair technician reported the lever was sticking.Lube/oil/clean 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 and will be returned to the customer upon completion of the service and repair process.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.

• 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: 5996074
• MDR Text Key: 56350441
• Report Number: 3003875359-2016-10530
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/16/2016

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: 8735273
• Other Device ID Number: (01)10887587010847(10)8735273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2016
• Initial Date FDA Received: 10/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2014
• 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