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 03/23/2017

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.Additional narrative: patient dob was sometime in 1955.Device is an instrument and is not implanted/explanted.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.A service & repair history was attempted; no service history review can be performed as part number 03.501.080 with lot number(s) 8209190 is a lot/batch controlled item.The manufacture date of this item is 14-dec-2012.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed.Device history records review was conducted.The report indicates that the: 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 during a coronary artery bypass graft (cabg) procedure on (b)(6) 2017, the zip fix applicator would not grasp, tighten or cut the zip fix implant.Reportedly, the zip fix implant was already around the sternal body.Another zip fix applicator was available for use and use to complete the surgery.Due to the reported events, the surgery was delayed by 15 to 20 minutes.No additional medication intervention was required.The procedure was successfully completed and the patient outcome was reported to be good at the end of the surgery.The malfunctioned device will be returned for investigation.This complaint involves one (1) device.Concomitant devices reported : zipfix implant (part # unknown, lot # unknown, quantity 1).This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device returned to manufacturer.A device history record (dhr) review was performed on part # 03.501.080, lot # 7516728: manufacturing location: (b)(4), manufacturing date: 16.Sep.2011.No non conformance reports (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.Reported service history review for part # 03.501.080, lot # 8209190 on medwatch report mw # 424327 is no longer applicable as lot number changed to 7516728.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 a coronary artery bypass graft (cabg) procedure was performed on (b)(6) 2017.

Manufacturer Narrative

A product development investigation was performed on the subject device.One application instrument for sternal zipfix (part number 03.501.080, lot number 7516728) was received with the complaint category of ¿does not/will not function: will not tension/tighten.¿ a visual inspection, device history record (dhr) review, functional test, and drawing review were performed as part of this investigation.The complaint condition is confirmed.When the trigger is released from the fully retracted position it sticks in the retracted position before returning to the resting state.Review of the failure mode and discussion with the product development subject matter expert determined that the condition is consistent with the result of not properly maintaining the device as indicated in the technique guide over the devices lifespan of 5+ years.Specifically, it is consistent with binding from inadequate lubrication.No new malfunctions were observed during the course of this investigation.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.Scrapping was observed on the surface of the bar attaching the trigger.The mating concomitant sternal zipfix implant was not returned.Thus, the device was functionally tested with an in-house demo implant (b)(6).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 in the retracted position before returning to the resting state.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.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)(6) service history review part 03.501.080, lot # 7516728.No service history review can be performed as part number 03.501.080 with lot number(s) 7516728 is a lot/batch controlled item.The manufacture date of this item is september 16, 2011.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed.Device 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: 6500033
• MDR Text Key: 73099427
• Report Number: 3003875359-2017-10189
• 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,Followup,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: 7516728
• 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: 04/18/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 04/21/2017; 05/18/2017; 05/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2011
• 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
• Patient Weight: 129