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

Model 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.Patient information not available for reporting.Device is an instrument and is not implanted/explanted.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.A service history evaluation/review was attempted on part #: 03.501.080; lot #: 8520341.The investigation of the complaint articles has shown that: no service history review can be performed as part number 03.501.080 with lot number(s) 8520341 is a lot/batch controlled item.The manufacture date of this item is unknown.The service history review is unconfirmed.Part 1 of 1.Device history records review was conducted.The report indicates that the: part #: 03.501.080; lot #: 8520341, manufacturing location: (b)(4), manufacturing date: 31.July 2013.No ncrs were 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.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 ziipfix was slipping during a surgery on an unknown date.There was no report of patient injury.This complaint involves 1 patient.This report is 1 if 1 for (b)(4).

Manufacturer Narrative

Returned to manufacturer.Service and repair evaluated the returned device.The customer reported the device was slipping.The repair technician reported the lever was not retracting properly, and the device could not be repaired.Binding is the reason for repair.The item is not repairable per the inspection sheet.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.

• 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: 6779008
• MDR Text Key: 82780032
• Report Number: 3003875359-2017-10393
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 10887587010847
• UDI-Public: (01)10887587010847(10)8520341
• 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: 07/14/2017

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 Model Number: 03.501.080
• Device Catalogue Number: 03.501.080
• Device Lot Number: 8520341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/14/2017
• Initial Date FDA Received: 08/09/2017
• Supplement Dates Manufacturer Received: 08/10/2017
• Supplement Dates FDA Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/31/2013
• 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