MAUDE Adverse Event Report: SYNTHES BETTLACH STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK; CERCLAGE FIXATION

Catalog Number 08.501.001.05S

Device Problem Break (1069)

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

Event Date 11/13/2015

Event Type  malfunction  

Manufacturer Narrative

Report was initially submitted on december 4, 2015, but the fda site was down.Advised by fda on december 9, 2015 to resubmit medwatch.Patient information is not available for reporting.This report will address one (1) sternal zipfix device that broke intra-operatively from a pre-packaged five (5) pack with lot number 9513032.(b)(4).Device broke intra-operatively and was not implanted or explanted.The complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn as no product was received.Device history record review: manufacturing site: (b)(4) - manufacturing date: september 10, 2015 - expiry date: september 30, 2020.No non-conformance reports were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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 two (2) zipfix ties broke during a coronary artery bypass graft on (b)(6) 2015.There were additional zipfix ties available.The procedure was completed successfully with no reported patient harm or surgical delay.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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.A product development investigation was performed for the subject device (part number 08.501.001.05s, lot number 9513032, sternal zipfix with needle).The subject device was examined and the compliant condition was able to be confirmed as the implant was received with the distal tip broken off and not returned.The break is roughly transverse and located where the proximal edge of the needle component would be captured inside the peek portion of the implant.A review of the current design drawing /manufactured revision was performed.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.The blunt needle is designed for peristernal application and is cut off prior to tensioning of the implant.The implant is part of the synthes sternal zipfix system.The system is intended for primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum technique guide.A definitive root cause was unable to be determined as the method of use which led to device failure was not provided, however the failure mode is consistent with incorrect technique/application of excessive force.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 / 5 PACK
• 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5276811
• MDR Text Key: 32996332
• Report Number: 9612488-2015-10607
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 08.501.001.05S
• Device Lot Number: 9513032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1