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

Catalog Number 03.501.080

Device Problems Device Operates Differently Than Expected (2913); Difficult to Advance (2920)

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

Event Date 04/14/2015

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event as follows: it was reported that a patient underwent a sternum closure procedure on (b)(6) 2015.During the operation, the handle to tighten the zipfix would not tension to the maximum amount.As a result, the surgeon had to tighten the zipfix ties manually.There was no reported time delay or patient harm.This report is 6 of 8 for (b)(4).

Manufacturer Narrative

Additional narrative: patient information is not available for reporting.Device is an instrument and is not implanted or explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).The investigation could not be completed; no conclusion could be drawn as no product was received.Device history review: manufacturing site: (b)(4) - manufacturing date: november 14, 2014.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.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

Additional narrative: subject device received; no conclusions could be drawn as the device is entering the complaint system.Device is 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

A product development evaluation was completed: the internal moving components of the returned second generation zipfix instrument showing only a few marks and scratches, which indicates a short time clinical use.No instrument screws are missing or loose.No damages or functional issues were identified.The performed handling test by product development with the returned instrument and 3 implants on a sternum bone model showed no functional deficiencies in tensioning and/or cutting the implants with the instrument.The tension applied is as per the design intent.There is no functional or design related issues identified on the returned instrument.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: 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: 4736231
• MDR Text Key: 15313455
• Report Number: 3003875359-2015-10196
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2015
• 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: 9246914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2014
• 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