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 Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/29/2017

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.Additional narrative: patient age, dob not available for reporting.Device is an instrument and is not implanted/explanted.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: dhr review for: part# 03.501.080, lot # 8209190; manufacturing location: (b)(4); manufacturing date: 14 december 2012.No ncr's were generated during production that would contribute to the complaint condition.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute to the 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

It was reported that the application instrument for sternal zipfix would not grasp/tighten or cut the sternal zipfix implant during a coronary artery bypass graft (cabg) procedure on (b)(6) 2017.The implant was already around the sternal body at the time.A backup application instrument for sternal zipfix was able to cut the same sternal zipfix implant and it remains implanted.Surgery was delayed fifteen to twenty minutes due to reasons unknown.The procedure was successfully completed.Patient outcome was reported as good.This complaint involves one device.Concomitant device reported: sternal zipfix implant (part# unknown, lot# unknown, qty 1).This report is 1 of 1 for (b)(4).

Manufacturer Narrative

A product development investigation was performed.One (1) application instrument for sternal zipfix (part number 03.501.080 / lot number 8209190) was received with the complaint category of ¿does not/will not function: will not tension/tighten.¿ a visual inspection, functional test, and drawing review were performed as part of this investigation.The complaint condition is confirmed because a trial implant could not be side loaded into the instrument and when the trigger is released from the fully retracted position it sticks slightly in the just before returning to the resting state.Appropriate actions have already taken to address the design issue of a tolerance stack resulting in the inability to side load the implant.Review of the trigger sticking and discussion with the product development subject matter expert determined that this condition of sticking is consistent with the result of not properly maintaining the device as indicated in the technique guide.Specifically, it is consistent with binding from inadequate lubrication.The sternal zipfix system technique guide provides instruction on the care and maintenance of this device and also instructions for lubricating the device prior to sterilization and includes this location as one of the three specific locations to oil directly.The returned device is part of the sternal zipfix system and used to tension and cut the sternal zipfix implants.Proper use and maintenance is addressed in the sternal zipfix system technique guide.The device was received intact with surface wear consistent with use.The mating concomitant sternal zipfix implant was not returned as it is reported to remain successfully implanted.Thus, the device was functionally tested with an in-house demo implant.The implant could not be side loaded into the instrument.In order to test the remaining functionality the implant was slid in from the front by pushing on the griping mechanism.The implant was securely held by the instrument.When the cutting mechanism is locked and the trigger is depressed, the trigger can be fully retracted.Then, when the trigger is released from the fully retracted position it sticks slightly just before returning to the resting state.This condition of not returning to the resting position has an influence on the opening angle of the cam-clamp component which impacts insertion of the implant into the instrument for tensioning and cutting.Thus, the complaint condition is confirmed, consistent with the reported condition, and can be replicated.The remaining functionality was tested and no further issues were determined.Relevant drawings, reflecting the current and manufactured revision, were reviewed.During the investigation no unaddressed product design issues or discrepancies were observed that may have contributed to the complaint condition.No new malfunctions were observed during the course of this investigation.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: 6509925
• MDR Text Key: 73336207
• Report Number: 3003875359-2017-10193
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 10887587010847
• UDI-Public: (01)10887587010847(10)8209190
• 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: 03/29/2017

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 Catalogue Number: 03.501.080
• Device Lot Number: 8209190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/29/2017
• Initial Date FDA Received: 04/20/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2012
• 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
• Treatment: STERNAL ZIPFIX IMPLANT (PART# UNK, LOT# UNK) QTY 1
• Patient Weight: 130