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

Model Number 03.501.080

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.A device history record review was performed for the subject device lot number 8533967.Manufacturing location: (b)(4).Date of manufacture: 27.Aug.2013.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.A service history record review was performed: no service history review can be performed as part number 03.501.080 with lot number(s) 8533967 is a lot/batch controlled item.The service history review is unconfirmed.A service and repair evaluation was performed: the customer reported the instrument was not gripping the zipfix tightly.The repair technician reported the one of the screws was damaged and could not be removed, and the other screws were loose.Damaged component is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The evaluation was confirmed.A product development investigation was performed for the subject device: the returned device is part of the sternal zipfix system and used to tension and cut the sternal zipfix implants.Proper use and maintenance is addressed in the sternal zipfix system technique guide.Visual and functional evaluation: the overall balance of the device looks in a very good condition with no wear signs on the device surface.No missing or broken components.Many of the screw recesses looked stripped.It is possible that the screws became stripped during an attempt to tighten the screws that had become loose of the period or an attempt was made to take apart the device possibly for cleaning purpose and then put back together.The repair technician too reported that the one of the screws was damaged and could not be removed, and the other screws were loose.It was observed that the trigger and hence the ratcheting component were not retracting to their original or resting-state when the trigger was released.This condition of not returning to the resting position has an influence on the opening angle of the cam-clamp component which impacts the tensioning ability of the device.Available in-house demo zipfix implant was inserted in the device, but the device was not able to pull and hence tension the zipfix.Based on the date of manufacture the following drawings, reflecting the current and manufactured revision, were reviewed.Drawings were reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.The loose screws were the root cause of the issue.It is possible that the screws became stripped/loose during an attempt to tighten the screws that had become loose of the period or an attempt was made to take apart the device possibly for cleaning purpose and then put back together.The exact root cause could not be determined.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 an application instrument for sternal zipfix is not gripping the zip fix tightly.No procedure involvement.Discovered during routine inspection.This is report 1 of 1 for (b)(4).

• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7013402
• MDR Text Key: 92609286
• Report Number: 3003875359-2017-10553
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 10887587010847
• UDI-Public: (01)10887587010847(10)8533967
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/27/2017

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 Model Number: 03.501.080
• Device Catalogue Number: 03.501.080
• Device Lot Number: 8533967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/27/2017
• Initial Date FDA Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2013
• 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