MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC APPLICATION INSTRUMENT FOR STERNAL ZIPFIX; CERCLAGE FIXATION

Model Number 03.501.080

Device Problems Failure to Cut (2587); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/11/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information is unknown.This report is for a zipfix applicator - unknown lot.Device is an instrument and is not implanted/explanted.Complainant part has not been returned for manufacturer review/investigation.The device remained in the patient.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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

The zip fix applicator would not clamp and cut the zipfix implant as intended during a coronary bypass procedure while being used on a patient on (b)(6) 2018.There was no reported surgical delay and the procedure was completed with another applicator.The reporter indicated there was no adverse event related to the product malfunction.There is one device involved in this complaint.This complaint involves one (1) device.This report is for one (1) applicator.(b)(4).

Manufacturer Narrative

Corrected data: udi, legal manufacture.The subject device has been received by the manufacturer and is undergoing investigation.The results of the investigation are pending completion and will be submitted in a supplemental report.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

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Lot number obtained from returned device.Subject device has been received and is currently in the evaluation process.Date reported in mwr-(b)(4) was 1/12/2018.Correct date should have been 1/11/2018 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

Device report from synthes canada reports an event in canada as follows: it was reported that during a coronary bypass procedure on (b)(6) 2018, the application instrument for sternal zipfix would not clamp and cut the zipfix implant as intended.No fragments were generated, procedure was completed utilizing a like instrument.Procedure was completed with no delay and no reported harm to patient.This report is for one (1) application instrument for sternal zipfix.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Dhr review was completed.Part no.: 03.501.080 , lot no.: 8863576 , manufacturing location: haegendorf , release to warehouse date: 06.Mar.2014.No 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.Customer quality conducted an investigation of the returned device.Service & repair evaluation the customer reported the instrument had an unknown issue.The repair technician reported the cutting level tab was bent which prevented the trigger from being pulled.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.At customer quality (cq), the returned application instrument for sternal zipfix was inspected and the complaint was confirmed.Visual inspection performed at cq observed that the cutting level tab component is bent which prevents the trigger from being pulled.The reported complaint condition was able to be replicated.Relevant drawings for the returned device were reviewed (both current and from the time of manufacture): top-level drawing for application instrument for sternal zipfix 03.501.080 and determined to be suitable for the intended design and application when used as recommended.A relevant dimensional analysis was not able to be accurately performed at cq due to post manufacturing damage.A device history review was performed for the returned instrument¿s lot number and no ncrs, mrrs or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.Also, based on the device history record review, there is no indication that any issues with material or material properties contributed to the complaint condition.While no definitive root cause could be determined it is possible that any excessive unintended forces encountered by the device during usage or handling could have contributed to the complaint condition of this 4+ year old reusable instrument.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7241846
• MDR Text Key: 99777528
• Report Number: 2939274-2018-50500
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 10887587010847
• UDI-Public: (01)10887587010847(10)LOTUNKNOWN
• Combination Product (y/n): N
• PMA/PMN Number: K110789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/11/2018

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: 8863576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2018
• Initial Date Manufacturer Received: 01/12/2018
• Initial Date FDA Received: 02/05/2018
• Supplement Dates Manufacturer Received: 03/30/2018; 03/30/2018; 05/07/2018
• Supplement Dates FDA Received: 04/20/2018; 04/24/2018; 05/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1