MAUDE Adverse Event Report: SYNTHES HAGENDORF APPLIC-INSTR F/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 Date 12/26/2016

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.(b)(6).Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records review was conducted.The report indicates that the: part 03.501.080 / lot 7635229; manufacturing location: (b)(4); manufacturing date: 21.Oct.2011.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

Device report from synthes on an event in (b)(6) as follows: it was reported that during surgery it was not possible to lock the implant with the application instrument properly.Patient is fine.The surgery was not prolonged.No information available about patient condition.This complaint involves 1 part.Concomitant medical products: 1x zipfix (part and lot unknown).This report is 1 of 1 for (b)(4).

Manufacturer Narrative

A product development investigation was performed on the subject device (application instrument for sternal zipfix, part # 03.501.080, lot # 7635229).There are no damages visible on the received instrument.Our investigation has shown that there are no damages visible on the received instrument.The manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.We have forwarded the received device to the responsible product development department for further evaluation with the following results: the returned instrument was compared in a functional test with the test instrument in regards to its handling as per the relevant surgical technique guide.It was found that the returned instrument is less smooth during its tensioning function when compared with the comparative test instrument.However, the returned instrument achieved the intended tensioning to the implant around the sternum bone model used.After the returned instrument had been lubricated, as per the manufactures instruction in the technique guide, the function was fully restored.Therefore we conclude that the returned instrument was incorrectly clinically reprocessed (insufficiently or not lubricated).No product fault could be detected.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: APPLIC-INSTR F/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: 6258750
• MDR Text Key: 65032148
• Report Number: 3003875359-2017-10023
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 07611819418424
• UDI-Public: (01)07611819418424(10)7635229
• Combination Product (y/n): N
• 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: 12/26/2016

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: 7635229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/20/2017
• Initial Date FDA Received: 01/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2011
• 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
• Treatment: 1X ZIPFIX (PART AND LOT UNKNOWN)