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 was used for treatment, not diagnosis.Additional narrative: device is an instrument and is not implanted/explanted.A service history record review was attempted for the subject device but could not be completed because the device is a lot-controlled item.The service history review is unconfirmed.A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.The subject device has been received and is currently in the evaluation process.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 two application instruments for sternal zipfix are not working.The nature of the problem was not specified.It was confirmed that there was no patient involvement and the issue was discovered on an unknown date outside of the operating room.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

A service history evaluation/review and investigation summary was performed.The investigation of the complaint articles has shown that: the customer reported the item was not working correctly.The repair technician reported the retaining nut was loose.Loose component is the reason for repair.The cause of the issue is unknown.The following parts were replaced: gen 1 handle screws a (7), gen 1 handle screws b (7).The item was repaired per the inspection sheet, passed synthes final inspection on 22-jun-2016 and will be returned to the customer upon completion of the service and repair process.The component was repaired and tested to operational specifications and returned to the customer.No cause was observed; no manufacturing or design issues were noted.No corrective action is required at this time.The evaluation was confirmed.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): 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: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5738980
• MDR Text Key: 47852899
• Report Number: 3003875359-2016-10370
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK110789
• 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
• Report Date: 06/07/2016

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: 7700691
• Other Device ID Number: (01)10887587010847(10)7700691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/07/2016
• Initial Date FDA Received: 06/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2011
• 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