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 Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.Pt age and weight: no patient involvement reported.Event date: unknown when device actually malfunctioned.Implant and explant dates: 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.Dhr review for: part#03.501.080, lot#8533967, manufacturing location: (b)(4), manufacturing date: 27.Aug.2013.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.A service & repair evaluation/review was attempted.A service history of the past three years for part number 03.501.080 with lot number(s) 8533967 has been reviewed.No service history review can be performed as the item has not previously been sent in for service.There is no relevant information to the current complained issue.The manufacture date of this item is unknown.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed 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 an application instrument for a zipfix system was not tensioning or releasing properly.There was no case or patient involvement.This complaint involves one part.Concomitant device: part: unknown zipfix, lot#unknown, quantity(unknown).This report is 1 of 1 for (b)(4).

Manufacturer Narrative

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

On (b)(6) 2016 update: reporter stated that unknown zipfix will not be returned for investigation and application instrument for a zipfix system was tested against the unknown zipfix by sterile processing technician and was confirmed that it was not tensioning or releasing properly.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: a service and repair evaluation was performed for the subject device (application instrument for sternal zipfix, part number 03.501.080, lot number 8533967).The subject device was returned with the complaint condition stating that the device was not working properly.The repair technician reported the lever was sticking, and several of the side screws on the handle were loose.¿loose component¿ is the reason for repair.The complaint condition is confirmed.The root cause of the issue is unknown.The following parts were replaced: gen 2 handle screws (qty 5).The item was repaired per the inspection sheet, passed synthes final inspection on 27-sep-2016 and will be returned to the customer upon completion of the service and repair process.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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5978698
• MDR Text Key: 55677025
• Report Number: 3003875359-2016-10516
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/08/2016

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: 8533967
• Other Device ID Number: (01)10887587010847(10)8533967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2016
• Initial Date FDA Received: 09/26/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/14/2016; 10/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2013
• 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: PART:UNKNOWN ZIPFIX, LOT#UNKNOWN, QUANTITY(UNKNOWN