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 Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 01/20/2017

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: device is an instrument and is not implanted/explanted.(b)(6).The subject device has been received and is currently undergoing investigation; the results are pending completion.A device history record review was performed for the subject device lot.Manufacturer: synthes (b)(4).Date of manufacture: jan 22, 2016.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.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 reported an event in (b)(46 as follows: it was reported that during surgery the application for sternal zipfix instrument was not holding the zipfix implant anymore.The surgery was not prolonged.There is no information available about patient condition and outcome for reporting.Concomitant reported part: 1x zipfix (part and lot unknown).This report is 1 of 1 for (b)(4).

Manufacturer Narrative

A product development evaluation was completed: there was no visual evidence of longer use on the trigger component.No design related root cause has been identified on the returned instrument.The root cause is related to insufficient or not performed lubrication during the clinical reprocessing.A product investigation was completed: the manufacturing documents were reviewed and no complaint related issues were found.The returned instrument was compared in a functional test with an internal test instrument in regards to its handling, as per the system 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 instrument still achieved the intended tensioning to the implant around a sternum bone model.Therefore, we could not replicate the complaint description.We also identified that when lubricated as per the manufacturer¿s instruction in the technique guide, no functional issue could be detected on the returned instrument.The technique guide covers the maintenance instruction of the application instrument.No product related issue 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.

Manufacturer Narrative

(b)(4).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

It was noted that the patient required sternal wire instead of sternal zipfix.The application instrument is not holding the sternal zipfix anymore.It is unknown if the surgery was delayed but the surgery was successfully completed.Updated concomitant device: sternal zipfix w/needle (part 08.501.001.01s, lot unknown, quantity 1).

• 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: 6331919
• MDR Text Key: 67498345
• Report Number: 3003875359-2017-10064
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 07611819418424
• UDI-Public: (01)07611819418424(10)9790426
• 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,Followup
• Report Date: 01/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.501.080
• Device Lot Number: 9790426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/20/2017
• Initial Date FDA Received: 02/15/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/21/2017; 04/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2016
• 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
• Treatment: UNKNOWN ZIPFIX IMPLANT, QUANTITY 1
• Patient Outcome(s): Required Intervention