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

Catalog Number 03.501.080

Device Problems Bent (1059); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.A service history record review was attempted for the subject device but could not be completed because the device is a lot/batch controlled item.The service history record review is unconfirmed.A device history record review was completed for the subject device lot.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.The subject device has been received and is currently in the evaluation process.A service and repair evaluation was performed for the subject device.The customer reported the item was not working properly.The repair technician reported the cutting lever tab was bent.¿bent¿ is the reason for repair; however, the item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to synthes customer quality for additional investigation.The service and repair evaluation was confirmed.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 is not working properly.It was confirmed that there was no patient involvement or procedure was involved and that the issue was discovered during routine inspection of the set by the reporter.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

A product investigation was completed: the complaint condition is confirmed.A visual inspection, functional test, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.It was determined that the trigger cannot be operated smoothly due to the bending of the spring stop components, especially the right component.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 as the device was reported to have been found in this condition during routine inspection.Thus, the root cause could not be definitively determined.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.Per the technique guide, this 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 technique guide.The device was received intact with a few wear marks and one area with sticky residue on the surface of the device.The spring stop components show bending to the left and one component additionally shows upwards bending.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 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.Thus, the complaint condition for this device is confirmed, consistent with the reported condition, and could be replicated.A review of the current top level design drawing/ revision at the time of manufactured was performed.The following component drawings were also reviewed; spring stop left assembly, spring stop component left, lever holder left, lever, spring stop right, lever holder right, pusher assembly, and the bolting component.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.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: 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: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5592157
• MDR Text Key: 43170823
• Report Number: 3003875359-2016-10251
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 03.501.080
• Device Lot Number: 8130975
• Other Device ID Number: (01)10887587010847(10)8130975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2012
• 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