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

Catalog Number 03.501.080

Device Problem Mechanical Jam (2983)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported during sterile processing while sales consultant was doing routine inspection of equipment that a zipfix gun, part# 03.501.080 was not working correctly.The trigger would stick when you squeezed it all the way.Eventually it did release.No patient involvement.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.Subject device has been received and is currently in the evaluation process.A device history review was conducted.The report indicates that no ncr's were generated during production that would contribute to the complaint condition.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute to the complaint condition.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

Additional narrative: a manufacturing investigation action was conducted/performed (mia).The report indicates that the: the review of the manufacturing documents has shown that there were no issues during the manufacturing process, which did contribute to the complained malfunction.The device did pass the 100% function test as required back then.The visual inspection shows that the device is a very good condition; there are almost no signs of use visible.Also all movable parts are movable as required; there is no grinding or stiffness.Therefore and because the device did pass the function test, after it was lubricated by the engineer, during the performed pd evaluation a manufacturing related fault can be excluded.A product evaluation was performed.The investigation of the complaint articles indicates that the: the product development evaluation if was found that the trigger of the instrument, as per the complaint description, did not always functioned freely.However, after the instrument was lubricated as per the manufacturer¿s instructions, the function of the instrument where fully restored and three implants could be tensioned and cut as per the design intent.The cause of the functional issue is related to the not preformed lubrication of the device by the user.No design related issues could be identified by product development.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 CH46 14; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH46 14; SZ CH4614
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4628491
• MDR Text Key: 5572286
• Report Number: 3003875359-2015-10156
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/11/2015

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: 8159386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/23/2015
• Initial Date FDA Received: 03/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2012
• 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