MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH APPLICATION INSTRUMENT FOR STERNAL ZIPFIX; CERCLAGE FIXATION

Model Number 03.501.080

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/21/2018

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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

Device report from synthes europe reports an event in (b)(6) as follows: it was reported during a coronary artery bypass grafting (sternal closure) procedure on (b)(6) 2018, the lever of the application instrument for strenal zipfix was not getting locked on the tensioning device before or after cutting the zipfix implants during sternum closure.The device was used with unlocked cutting lever as action taken to manage the problem during the procedure.The malfunction occurred after using the device multiple times.There was a surgical delay of 10 minutes.Patient outcome is unknown.Concomitant device reported: unknown zipfix implant (part # unknown, lot unknown, quantity unknown).(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.A device history record (dhr) review was conducted for part: 03.501.080, lot: 9790420: manufacturing site: hägendorf, release to warehouse date: 31.Mar.2016: the device history record shows this lot of (b)(4) pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.A product investigation was conducted.Visual inspection visual inspection observed that the application-instrument f/sternal zipfix (2nd generation instrument design) with no visual evidence of extensive use on the trigger component.Functional test / dimensional inspection: it was determined that the functionality of the device cutting lever was impaired.The cutting lever could not be locked in the device holding feature.Document/specification review: not required per selected investigation flow.Summary: the received condition of the application-instrument f/sternal zipfix is concordant with the complaint description and the complaint condition is confirmed.The review of the device history records showed that this instrument was manufactured in march 2016 according to the specifications.The articles conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities reported.We found that the cutting lever is deformed to such an extent that the section nearest to the cutting feature at the front of the instrument is contacting the device housing.This contact prevents the cutting lever to lower itself far enough into the holding feature.Because of that the user cannot apply any tension to the implant with the instrument.We determined that there is no design related root cause which could be related to the intra operative device failure.The cause of this cutting lever deformation cannot be determined since multiple causes are possible (user, handling during clinical repossessing or dropping to the floor).Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.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 is now known.Date of manufacture is now known.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A device history records review has been requested.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): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7692016
• MDR Text Key: 114152542
• Report Number: 8030965-2018-55074
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 10887587010847
• UDI-Public: (01)10887587010847
• 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
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2018
• 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: 9790420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• Date Manufacturer Received: 08/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1