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 Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: event date: unknown.Device is an instrument and is not implanted/explanted.Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records review was conducted.The report indicates: part # 03.501.080, lot # 7858407, manufacturing location: (b)(4), manufacturing date: 18.Apr.2012.No ncrs 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.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 from the detroit metro office that the sternal zipfix application instrument does not adequately clamp the zipfix implant.There was no reported patient involvement.This complaint involves two devices.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: a product development investigation was performed for the subject device.The returned application instrument for sternal zipfix (03.501.080, 7858407) is used in the sternal zipfix system for fast sternal closure with consistent tension along a sternotomy or fracture of the sternum.The application instrument is used to apply and tighten sternal zipfix implants.The returned application instrument was inspected upon receipt and its complaint condition could not be replicated.A zipfix implant was not available to be tested, however while inspecting the region of the application instrument which is designed to clamp onto zipfix implants it appeared that the components of the application instrument were intact and functioned as intended and therefore the complaint condition was unconfirmed.As part of this investigation a visual inspection, drawing review, and root cause analysis were performed.The returned application instrument for sternal zipfix (03.501.080, 7858407) was manufactured on 18apr12 and drawings were reviewed and determined to be suitable for the intended design, application, and dimensional conformity when used and handled as recommended.The design updates implemented would not directly impact the complaint condition.No mrrs, ncrs, or actions related to the complaint condition were generated during production of the returned part(s).Based on the available information it is not possible to determine a definitive root cause for the complaint condition.Since the subject sternal zipfix implant was not returned, it is not possible to try and recreate the same exact situation which was claimed to have occurred in order to cause the complaint condition.It is possible that damage to the teeth of the zipfix which was used could have contributed to the inadequate clamping noticed during the complaint condition.Upon inspection of the returned application instrument, its trigger feature and the teeth of the component designed to grip/tighten zipfix implants seemed intact and as if it would be capable of engaging with implants as intended.During the investigation no unidentified product design issues or discrepancies were observed that may have contributed to the complaint condition.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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6259262
• MDR Text Key: 65033851
• Report Number: 3003875359-2017-10025
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 10887587010847
• UDI-Public: (01)10887587010847(10)7858407
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2017
• 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: 7858407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2012
• 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