MAUDE Adverse Event Report: SYNTHES BETTLACH STERNAL ZIPFIX WITH NEEDLE STERILE; CERCLAGE FIXATION

Catalog Number 08.501.001.01S

Device Problem Unintended Movement (3026)

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

Event Date 11/02/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Due to intra-operative issues, device was not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Manufacturing location: (b)(4).Supplier: (b)(4).Manufacturing date: october 04, 2016.Expiry date: october 04, 2020.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a female patient underwent a coronary artery bypass graph (cabg) procedure on (b)(6) 2016.During the surgery while the surgeon was closing the sterno with the zip fix system, one of the ties came unraveled.The surgeon had three sternal zipfix with needle sterile ties in, and when he went to cut the fourth sternal zipfix with needle sterile tie, it came unraveled.He then had to open the other three zip ties and start all over again.There were no fragments generated and no x-rays needed.There was no other surgical medical intervention.There was a surgical time delay of approximately five minutes.The surgery was successfully completed and the patient status outcome is stable.Concomitant devices reported: sternal zipfix with needle sterile ties (part 08.501.001.01s, lot l088732, quantity 3).This is report 1 of 1 for com-(b)(4).

Manufacturer Narrative

Udi: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional narrative: the manufacturer investigation results are as follows.The returned implant was examined and the complaint condition could not be replicated although damage to the teeth of the zipfix is consistent with significant force that likely led to the unraveling of the tie.One end of the zipfix was cut clean and was not frayed.The segment that would contain the needle was not returned.The specific details regarding the application of force and method of use are unknown; therefore, no definitive root cause was able to be identified.However, returned condition is consistent with implant failure as the result of the application of excessive forces prior to tensioning of the implant.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.A visual inspection, functional test and drawing review were performed as part of this investigation.This complaint is confirmed.The sternal zipfix system is indicated for primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.Per technique guide for the sternal zipfix system (j10267-c), five (5) zipfix implants are recommended for a full midline sternotomy when no other plates are used for fixation.The returned implant was examined and the complaint condition could not be replicated although damage to the teeth of the zipfix is consistent with significant force that likely led to the unraveling of the tie.One end of the zipfix was cut clean and was not frayed.The segment that would contain the needle was not returned.The specific details regarding the application of force and method of use are unknown; therefore, no definitive root cause was able to be identified.However, returned condition is consistent with implant failure as the result of the application of excessive forces prior to tensioning of the implant.Relevant drawings for the returned implant were reviewed (current revision as manufacture date is unknown): (b)(4) (1118-607_samaplast revision a).The design, materials and finishing processes were found to be appropriate for the intended use of these devices.A device history review was performed for the returned implant's lot number and no mrrs, ncrs or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.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: STERNAL ZIPFIX WITH NEEDLE STERILE
• Type of Device: CERCLAGE FIXATION
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6135681
• MDR Text Key: 61146223
• Report Number: 9612488-2016-10486
• 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: 11/07/2016

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 Expiration Date: 10/04/2020
• Device Catalogue Number: 08.501.001.01S
• Device Lot Number: L088632
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/07/2016
• Initial Date FDA Received: 11/30/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/04/2017; 01/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 3 PART 08.501.001.01S, LOT L088732, STERNAL ZIPFIX