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

Catalog Number 03.501.080

Device Problem Dull, Blunt (2407)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

No patient involvement reported.Date of event is unknown.Device is an instrument and is not implanted / explanted.Service history review was attempted for part# 03.501.080, lot# 8652176.No service history review can be performed as part number 03.501.080 with lot number 8652176 is a lot/batch controlled item.The release to warehouse date of this item is (b)(6) 2013.The service history review is unconfirmed.Device history records review was completed for part# 03.501.080, lot# 8652176.Manufacturing location: (b)(6), manufacturing date: oct 10, 2013.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The device was received and the product evaluation is in progress.No conclusion can be drawn.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

The service and repair department documented that three (3) application instruments for sternal zipfix are not cutting.No patient involvement reported.This report is for one (1) application instrument for sternal zipfix.This is report 3 of 3 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A service and repair evaluation was performed.The customer reported the item was not cutting.The repair technician reported the cutting lever tab was bent.Bent is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.A product investigation was performed.Application instruments for sternal zipfix [part number 03.501.080 / lot number 8652176 (quantity 1)] was received with the complaint category of ¿does not/will not function: will not cut/dull.¿ the repair technician reported the cutting lever tab was bent.Thus, the complaint condition is confirmed as this would impact the tensioning and cutting function of the device.The item was not repairable per the inspection sheet and therefore forwarded to customer quality.A device history record (dhr) review, service and repair evaluation, visual inspection, and drawing review were performed as part of this investigation.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.The device was received intact with surface wear consistent with use.One of the spring stop components shows bending toward midline and upwards and the other shows slight bending away from midline.Scraping was observed on the outer surface of the upward bent spring.When the cutting mechanism is unlocked, the trigger is locked as intended so that the device would not cut with the implant under tension.When the cutting mechanism is locked, the trigger does compresses and release as intended.Although the cutting lever is still retained in the locked position, due to the bending the cutting lever is not being held intended.Thus, the complaint condition is confirmed and consistent with the reported condition.Replication of the complaint condition is not applicable as the component is already bent.It would be expected that only a high force, likely applied to the lever or the spring directly, would lead to bending of the locking springs in this nature.However, the specific circumstances that resulted in bending are unknown.Thus, the root cause could not be definitively determined.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 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: 6147736
• MDR Text Key: 61615338
• Report Number: 3003875359-2016-10635
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2016
• 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: 8652176
• Other Device ID Number: (01)10887587010847(10)8652176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2013
• 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