MAUDE Adverse Event Report: SYNTHES USA STERNAL ZIPFIX WITH NEEDLE DEMO/5 PACK; CERCLAGE FIXATION

Catalog Number D000061

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 11/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device is a demo product and is not implanted/explanted.A product investigation was completed: the device was received with the distal needle portion cut off.The device shows minor wear consistent with multiple uses as a demonstration sample.This complaint is not confirmed.The complaint condition of the zip fix implant not tightening could not be replicated at customer quality (cq) as the tensioning device/application instrument was not returned.A visual inspection under 5x magnification and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.A review of the device history records was unable to be performed since the lot number was unknown.The returned sternum zipfix demo sample is a demonstration sample which is intended for training purposes and is not intended for human use.The relevant drawing was reviewed during this investigation.No product design issues or discrepancies were observed.Unable to determine a definitive root cause as this complaint could not be confirmed or replicated at cq.It is possible that multiple uses as a demonstration sample has led to the device being worn to an extent that it will no longer function as intended.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 a zipfix implant (sternal zipfix with needle demo/5 pack) was stripped and would not tighten.This was a sample used for demonstration purposes only.This was discovered outside of the operating room during a demonstration.No surgery or patient involvement.While the device was being investigated by the manufacturer it was noted that the device was received with the distal needle portion cut off.The device shows minor wear consistent with multiple uses as a demonstration sample.This is report 1 of 1 for com-(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.

• Brand Name: STERNAL ZIPFIX WITH NEEDLE DEMO/5 PACK
• Type of Device: CERCLAGE FIXATION
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6221117
• MDR Text Key: 63813062
• Report Number: 2520274-2017-10015
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/08/2016

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: Medical Equipment Company Technician/Representative
• Device Catalogue Number: D000061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/19/2016
• Initial Date FDA Received: 01/04/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1