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 Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

There was no known reported patient involvement associated with the complained event.Date of event: unknown when device malfunctioned.Device is an instrument and is not implanted/explanted.A service history review (shr) has been requested.The device has been 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

It was reported that the application instrument for sternal zipfix is not working correctly; the trigger is not functioning properly.The trigger on the zipflix is not tensioning and is loose.This was discovered in sterile processing.There was no patient involvement.This report is for one (1) application instrument for sternal zipfix.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

No service history review can be performed as part number 03.501.080 with lot number(s) 7831855 is a lot/batch controlled item.The manufacture date of this item is unknown.The service history review is unconfirmed.Device history records review was completed for part# 03.501.080, lot# 7831855.Manufacturing location: (b)(4), manufacturing date: mar 28, 2012.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.Service and repair evaluation was completed.The customer reported the trigger of the zipfix was not tensioning and was loose.The repair technician reported the complaint condition could not be duplicated, but the top of the cutting tip was broken off.Damaged component 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.

Manufacturer Narrative

Customer quality (cq) engineering investigation: the device received at cq location was checked for different operational aspects to identify any kind of malfunctioning.No issue was observed with the returned device regarding functioning of the device trigger.The nose piece which cuts the zipfix was found to be broken.The broken fragment is missing.The complaint condition of ¿will not tension¿ was not able to be confirmed, but the nose piece of the instrument was found to be broken, which would also prevent the instrument from tensioning as intended, therefore the complaint condition was confirmed and its replication is inapplicable.Visual inspection, device history record (dhr) review, shr review, service & repair evaluation and drawing review were performed as part of this investigation.The returned device is used under sternal zipfix system to tension the sternal zipfix implants to achieve desired reduction and to cut them in the locking position.Visual inspection: the overall balance of the returned device looks in marginally worn condition with some signs of surface wear.The instrument was checked for different operational aspects to identify any kind of malfunctioning.No issue was observed with the returned device functioning of the device trigger.The nose piece which cuts the zipfix was found to be broken.The broken fragment is missing.Drawings were reviewed.The instrument was found to be manufactured per applicable drawing no drawing issues or discrepancies were noted.The design is adequate for its intended use and did not contribute to this complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition of the broken cutter.During use the device is intended to cut sternal zipfix implants which are specified as peek optima lt3 per drawing compared to the cutter which is hardened and tempered 1.4112 stainless steel (52 +4/0 hrc) per drawing.The design of the cutter and cutter assembly were determined to be suitable for the intended use when employed and maintained as recommended.Review of the failure mode determined that it is most probable that impact (such as being dropped) resulted in the complaint condition as a break of this nature would require significant force.However, since it is unknown when and how the damage occurred, a root cause cannot be definitively determined.Based on the lack of detailed information provided, it is not possible to determine a definitive root cause.Upon inspection of the returned instrument and considering the way it is used in surgery it is not likely that the broken cutting edge occurred during routine usage.The sternal zipfix system technique guide states that the user must avoid over-tensioning of implants, improper maintenance of instrument, improper positioning of cutting edge of the instrument in respect to implants, and improper positioning of the cutting lever when tensioning and cutting.In addition to not following the guidance provided in the technique guide it is possible that if the instrument was exposed to an unexpected significant impact due to mishandling it could have caused the cutting edge to break.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: 6801906
• MDR Text Key: 83131645
• Report Number: 8030965-2017-14436
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 10887587010847
• UDI-Public: (01)10887587010847(10)7831855
• 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,Followup
• Report Date: 08/03/2017

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: 7831855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/03/2017
• Initial Date FDA Received: 08/17/2017
• Supplement Dates Manufacturer Received: 08/24/2017; 09/25/2017
• Supplement Dates FDA Received: 09/15/2017; 09/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2012
• 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