MAUDE Adverse Event Report: SYNTHES HAGENDORF APPLICATION INSTRUMENT FOR STERNAL ZIPFIX; CERCLAGE FIXATION

Catalog Number 03.501.080

Device Problem Sticking (1597)

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

Event Date 09/17/2015

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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

It was reported that the application instrument for sternal zipfix is sticking.During a sternotomy for a mitral valve replacement the surgeon was closing the sternum with zipfix.The surgeon noticed that the tip of the application instrument was sticking, making it difficult to tighten the zip-ties.The surgeon continued to use the application instrument until all of the zip-ties were fully tightened, however the surgery was delayed approximately ten (10) minutes.The surgery was completed and the patient is doing well.There is no additional information.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Service history review was attempted: part no: 03.501.080, lot no: 8707958 no service history review can be performed as this is a lot controlled item.The manufacture date of this item is 22-nov-2013.The source of the manufacture date is the release to warehouse date.The service history evaluation is unconfirmed.A service history evaluation/review was performed.The investigation of the complaint articles has shown that: the customer reported the tip of the zip gun was sticking.The repair technician reported the lever was sticking.Lube/oil/clean is the reason for repair.The cause of the issue is unknown.No parts were replaced.This item was repaired, passed synthes final inspection and returned to the customer on 9-oct-2015.The evaluation was confirmed.Part 1 of 1.An investigation summary was performed.The investigation of the complaint articles has shown that: synthes manufacturing location was discovered upon receipt of subject device.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Synthes manufacturing location was discovered upon receipt of subject device.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 CO CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CO CH461 4; SZ CH4614
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5113317
• MDR Text Key: 27104161
• Report Number: 2520274-2015-16330
• 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: Followup,Followup
• Report Date: 09/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2015
• 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: 8707958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2013
• 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
• Patient Weight: 59