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

Catalog Number 03.501.080

Device Problems Device Operates Differently Than Expected (2913); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: event date: unknown.Device is an instrument and is not implanted/explanted.(b)(4).The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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

Device report from synthes europe reports an event in (b)(6) as follows: service technician identified the following: general deformed bent and clamping lever is blocked, guide in shear lever is bent.The device failed the tightening functional check during pretest.There were no injuries, patient user involvement or surgery delay or need for additional medical intervention reported.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

A device history record (dhr) review was performed on part # 03.501.080, lot # 8289116.Manufacturing location: (b)(4), manufacturing date: 05.Feb.2013.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 the product that would contribute to this complaint condition.A product investigation was performed.Service technician identified the following: general deformed bent and clamping lever is blocked, guide in shear lever is bent.The device failed the tightening functional check during pretest.The service technician noted the following action taken: _tea_ exchange, replacement.Technician note: clamping lever is blocked; guide in shear lever is bent.Functional testing of the device has been performed in accordance with the service manual.The service technician identified the probable root cause: _egb_ undetermined - not determinable.Based on the information received and reported on the complaint file, no relevant service history, and the fact that the cause of failure reported is undeterminable, a corrective and preventative action (capa) is not proposed.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: 6128788
• MDR Text Key: 60939721
• Report Number: 3003875359-2016-10618
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/19/2016

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: 8289116
• Other Device ID Number: (01)07611819418424(10)8289116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/19/2016
• Initial Date FDA Received: 11/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2013
• 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