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

Catalog Number 03.501.080

Device Problems Bent (1059); Material Distortion (2977)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Patient information is not available for reporting.Date of event is unknown.Device is an instrument and is not implanted / explanted.Device history records review for part # 03.501.080, lot # 8725323 has been completed.Manufacturing location: (b)(4), manufacturing date: nov 27, 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.Service and repair evaluation was completed.The customer reported the instrument appeared to be bent and did not function properly.The repair technician reported the right side guide was bent, and the lever was sticky.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.The device was received and the product evaluation is in progress.No conclusion can be drawn.Device 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 the application instrument for sternal zipfix appeared bent and does not function properly.This was noticed during an intraoperative procedure.Another zipfix application instrument was available for use.The procedure was completed successfully with no surgical delay reported.There was no patient harm and there is no additional patient information available.This report is for one (1) application instrument for sternal zipfix.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

No service history review can be performed as part number 03.501.080 with lot number 8725323 is a lot/batch controlled item.The manufacture date of this item is december 04, 2013.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed.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

Device was used for treatment, not diagnosis.The manufacturers evaluation results are as follows.The device was received intact with a few wear marks consistent with use.The complaint condition is confirmed as the device was received with one of the spring stop components shows bending toward midline and upwards.When the cutting mechanism is locked, the trigger does not compresses and release as intended.It was noted that if additional force was applied, pushing the rod further into the lock position, the trigger then could move though the full range of motion.However, when the trigger is released from the fully retracted position it sticks in the far position before returning to the resting state.The root cause was determined to be a combination of force applied to the spring stop component and binding of the pusher assembly.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6064187
• MDR Text Key: 58746536
• Report Number: 3003875359-2016-10567
• 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,Followup
• Report Date: 10/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2016
• 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: 8725323
• Other Device ID Number: (01)10887587010847(10)8725323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2013
• 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