MAUDE Adverse Event Report: SYNTHES BETTLACH STERNAL ZIPFIX WITH NEEDLE STERILE/20 PACK; CERCLAGE FIXATION

Catalog Number 08.501.001.20S

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 03/13/2017

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient identifier and age at time of event and/or date of birth are not available for reporting.Other number¿udi: (b)(4).Due to the intra-operative events, the device was not successfully implanted.An alternate device was used to complete procedural step.As such, implant/explant dates are not applicable.The subject device has been received and is currently undergoing investigation.A device history record review was performed for the subject device lot.Manufacturer: (b)(4).Date of manufacture: jan 31, 2017.Expiration date: jan 31, 2022.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.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 patient had heart surgery on (b)(6) 2017.The surgeon was using the sternal zip fix system.As the surgeon was closing the patient¿s sternum, he attempted to implant the fifth sternal zipfix with needle.The fifth zipfix implant would not ratchet down when using the application instrument.The surgeon cut and removed this zipfix and to implanted another zipfix in its place.No fragments were generated.A total of six 6 zipfix devices were implanted in the patient sternum.Due to this event no additional procedure time was added and surgery was completed successfully.The patient is reported in stable condition.Concomitant device: application instrument for sternal zipfix (item 03.501.080, lot # unknown, quantity 1 each).This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: a product development investigation was performed for the subject device.This complaint is not able to be confirmed at cq.Only a portion of the implant was received at cq for evaluation.The returned portion measures approximately 100mm in length using calipers.This complaint was not able to be replicated at customer quality (cq) because the returned device has already been cut and the application instrument also involved in the complaint event was not returned.No new malfunctions were identified.A visual inspection under 5x magnification and drawing review were performed as part of this investigation.Drawing was reviewed during this investigation.No product design issues or discrepancies were observed.Unable to determine a definitive root cause as this complaint is unconfirmed.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: STERNAL ZIPFIX WITH NEEDLE STERILE/20 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6459099
• MDR Text Key: 71733095
• Report Number: 9612488-2017-10151
• 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
• Report Date: 03/13/2017

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: 01/31/2022
• Device Catalogue Number: 08.501.001.20S
• Device Lot Number: L230609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/13/2017
• Initial Date FDA Received: 04/04/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 03.501.080, APPL INST FOR STERNAL ZIPFIX, QTY 1
• Patient Weight: 80