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

Catalog Number 03.501.080

Device Problems Sticking (1597); Mechanical Jam (2983)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 12/15/2014

Event Type  Injury  

Event Description

It was reported three zip fix application instruments had difficulties tensioning and all three eventually jammed.The surgeon decided to remove the sternal zipfix ties and replace them with sternal wires to complete the surgery.A surgical delay of less than 30 minutes was reported.The patient was sent to the cardiac care unit (ccu) in critical condition post-operatively.This report is 2 of 4 for (b)(4).

Manufacturer Narrative

(b)(6).Device is an instrument and is not implanted/explanted.Device was returned to manufacturer for review/investigation on (b)(4) 2014.The investigation could not be completed; no conclusion could be drawn as the product is entering the complaint system.Device history review: 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 manufactured in (b)(4) on february 14, 2013.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.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: a product development investigation was performed for the subject device.The ¿second generation¿ instrument (subject device), part number 03.501.080, was returned to the manufacturer showing no or little marks on its moving parts which indicate a limited use of the device.No screws have been found to be loose or missing.No other damages are identified.The subject device was inspected for its functionality and an application test with three implants was performed.All three implants could be tensioned and cut as per the design intent.The trigger of the instrument for tensioning the implant did not always function freely and did not returned to its indented resting position.This has also an influence on the opening angle of the cam-clamp component of the instrument which must open far enough to receive the next or new implant for tensioning and/or cutting.It was found that the returned instrument had not been lubricated as per the instructions provided by the manufacturer.After the lubrication by the investigator of the instrument the function of the instrument was fully restored.The root cause of this functional issue is related to the not preformed lubrication of the device by the end user.No design related issues could be identified by product development.The product development investigation of the subject device concluded the complained condition is unconfirmed.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 CH46 14; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH46 14; SZ CH4614
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4401727
• MDR Text Key: 5302403
• Report Number: 3003875359-2015-10024
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.501.080
• Device Lot Number: 8290968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2013
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 18 YR
• Patient Weight: 64