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

Catalog Number 03.501.080

Device Problem Dull, Blunt (2407)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: no patient involvement reported.Date of event is unknown.Device is an instrument and is not implanted / explanted.Service history review was attempted for part # 03.501.080, lot # 9761211.No service history review can be performed as part number 03.501.080 with lot number 9761211 is a lot/batch controlled item.The release to warehouse date of this item is mar 31, 2016.The service history review is unconfirmed.Device history records review was completed for part # 03.501.080, lot # 9761211.Manufacturing location: (b)(4), manufacturing date: mar 24, 2016.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The device was received and the product evaluation is in progress.No conclusion can be drawn.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

The service and repair department documented that three (3) application instruments for sternal zipfix are not cutting.No patient involvement reported.This report is for one (1) application instrument for sternal zipfix.This is report 1 of 3 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis a service and repair evaluation was performed.The customer reported the item was not cutting.The repair technician reported the retaining nut was loose.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 23-dec-2016 and will be returned to the customer upon completion of the service and repair process.The evaluation was confirmed.Service history review was attempted for part# 03.501.080, lot# 9761211.No service history review can be performed as part number 03.501.080 with lot number 9761211 is a lot/batch controlled item.The release to warehouse date of this item is mar 30, 2016.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.

• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6147746
• MDR Text Key: 61615931
• Report Number: 3003875359-2016-10633
• 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
• Report Date: 11/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2016
• 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: 9761211
• Other Device ID Number: (01)10887587010847(10)9761211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2016
• 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