MAUDE Adverse Event Report: SYNTHES BETTLACH STERNAL ZIPFIX WITH NEEDLE STERILE; CERCLAGE FIXATION

Catalog Number 08.501.001.01S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 09/22/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device malfunctioned intra-operatively and was not implanted / explanted.(b)(4) the complaint indicated that the sternal zip fix device would not catch to the end hole of the device, the peek inside the end hole of the device was crooked and would not align with the teethed surface.Therefore, the surgeon decided to use a combination of unknown wires and a sternal plate which is a change in the index procedure.Device history records review was conducted.The report indicates that the: part 08.501.001.01s lot l275984 manufacturing location: (b)(4) supplier: (b)(4) manufacturing date: 13.June 2017 expiry date: 13.June 2022 no anomalies were detected during device history record review.No ncrs were generated during production.Review of the device history record 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

It was reported that a patient underwent a coronary artery bypass graft (cabg) with sternal fixation on (b)(6) 2017.Two sternal zip fixes were planned for use.The surgeon had no problem with the first sternal zip fix.However, the second sternal zip fix device would not catch to the end hole of the device (the peek inside the end hole of the device was crooked and would not align with the teethed surface.Therefore, the surgeon decided to use a combination of unknown wires and a sternal plate.There were a few minutes (exact time unknown) delay to fix the issue.The rest of the procedure was completed successfully.There is no patient harm reported.No additional information is available.This complaint involves one (1) part.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Customer quality conducted an investigation of the returned device.The returned implant was examined and the complaint condition was able to be confirmed.The locking platform of the locking head was slightly sunken and depressed at about a 10 degree angle which prevented the zipfix from catching the toothed surface when functionally tested.The implant was scratched in several locations, included including a crimped imprint and scratches around the locking head near the titled platform.This is indicative of using a forcep like device such as the needle holder around the locking housing.The circumstances around use and damage are unknown, a definitive root cause could not be determined but the damage is inconsistent with common traces of tightening with the application instrument 03.501.080 as per surgical technique.It was also noted that the needle had been cut off at the notch.It is specifically stated in the technique guide to cut the zipfix below the notch.This would minimize the chance of metal debris from accidently cutting part of the needle.A visual inspection, functional test, drawing review, and device history record review were performed as part the investigation.The sternal zipfix system is indicated for primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.Per technique guide for the sternal zipfix system, five (5) zipfix implants are recommended for a full midline sternotomy when no other plates are used for fixation.Relevant drawings for the returned instrument were reviewed.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.Because of the damage the complaint relevant dimensions cannot be checked to specifications anymore.The dhr review shows that the production procedure was according to the specifications at the manufacturing and there were no issues that would contribute to this complaint condition.The sternal zipfix dcrm was reviewed.The complaint is adequately addressed by the risk assessment.The circumstances around use and damage are unknown, a definitive root cause could not be determined but the damage is inconsistent with common traces of tightening with the application instrument 03.501.080 as per surgical technique.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

Udi: (b)(4).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.Report was initially submitted on nov 1, 2017, but the fda site was down.Advised by fda on nov 6, 2017 to resubmit medwatch.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: STERNAL ZIPFIX WITH NEEDLE STERILE
• Type of Device: CERCLAGE FIXATION
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6963281
• MDR Text Key: 89808869
• Report Number: 9612488-2017-10533
• Device Sequence Number: 1
• Product Code: JDQ
• 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: 09/22/2017

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 Expiration Date: 06/13/2022
• Device Catalogue Number: 08.501.001.01S
• Device Lot Number: L275984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/22/2017
• Initial Date FDA Received: 10/19/2017
• Supplement Dates Manufacturer Received: 11/01/2017; 11/20/2017
• Supplement Dates FDA Received: 11/08/2017; 11/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention