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  

Event Description

It was reported that two zip fix application instruments did not lock.It was also reported that 3 devices would not tension/tighten and that there was no patient involvement.This report is 2 of 3 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: unknown when the device stopped working.Device is an instrument and is not implanted/explanted.The investigation could not be completed; no conclusion could be drawn, as the product is entering the complaint system.A review of the device history records was performed and no complaint related issues were found.Manufacturing location: (b)(4), manufacturing date: 21.Jun.2013, no ncrs were generated during production if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

A product development investigation was performed for the subject device (part number 03.501.080, application instrument for sternal zipfix, lot number 8447972).The subject device was returned with the complaint ¿will not tension/tighten.¿ the subject device is a second generation instrument and was received with no components, screws or nuts loose or missing.The product development investigation included visual inspection, design evaluation and functional testing.The performed handling test by product development on the returned instrument with three implants on a sternum bone model showed no functional deficiencies in tensioning and/or cutting the implants with the instrument.The tension applied is as per the design intent.No damages or functional issues were identified.There are no functional or design-related issues identified for the returned instrument.The complaint condition was not confirmed.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: 4806586
• MDR Text Key: 5830550
• Report Number: 3003875359-2015-10237
• 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: 05/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2015
• 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: 8447972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2013
• 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