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

Catalog Number 03.501.080

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 06/06/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information is not available for reporting.Device is an instrument and is not implanted/explanted.The subject device is expected to be returned to the synthes manufacturer for evaluation but has not yet been received.Reporter¿s last name was not available for reporting.A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product or any subcomponents that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 during an open heart surgery on (b)(6) 2016, the application instrument for sternal zipfix would not tension or tighten.The surgeon was able to use another instrument that was available for use to successfully complete the procedure.There was no surgical delay.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: product investigation summary: one (1) application instrument for sternal zipfix (part: 03.501.080 / lot: 9742688) was received with the complaint category of ¿does not/will not function: will not tension/tighten.¿ a visual inspection, functional test, and drawing review were performed as part of this investigation.The complaint condition is confirmed as the trigger sticks slightly in the far position after being released from the fully retracted position.The remaining functionality was tested and no further issues were determined.The failure mode is consistent with the result of not properly maintaining the device as indicated in the technique guide.Specifically, it appears binding may be occurring between the spacer component and the pusher sleeve component when the device is not adequately lubricated as this is where the tolerance is tightly constrained to allow a sliding fit to ensure proper alignment between the components.However, as the details regarding the use and maintenance of this device are unknown, a root cause cannot be definitively determined.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.The investigation shows that this device is part of the sternal zipfix system and is used to tension and cut the sternal zipfix implants.Proper use and maintenance is addressed in technique guide.The device was received intact with only light scratch wear.Residue, likely related to maintenance, was observed on the inner surfaces of the device.The device was functionally tested with an in-house demo implant, which was securely held by the instrument.When the cutting mechanism is locked and the trigger is depressed, the trigger can be fully retracted.Then, when the trigger is released from the fully retracted position, it sticks slightly in the far position before returning to the resting state.Thus, the complaint condition is confirmed, consistent with the reported condition, and can be replicated.The remaining functionality was tested and no further issues were determined.A review of the current design drawing at the time of manufacture for the assembly was performed.The following component drawings were also reviewed: spring assembly, pusher assembly, spacer, and pusher sleeve.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.The sternal zipfix system technique guide provides instruction on the care and maintenance of this device.Instructions for lubricating the device prior to sterilization are included and direct the user to one of the three specific locations to oil directly.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint.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.

• 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: 5741643
• MDR Text Key: 47934584
• Report Number: 3003875359-2016-10380
• 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,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/07/2016

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: Health Professional
• Device Catalogue Number: 03.501.080
• Device Lot Number: 9742688
• Other Device ID Number: (01)10887587010847(10)9742688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2016
• Initial Date FDA Received: 06/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2015
• 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