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

Catalog Number 03.501.080

Device Problems Failure To Adhere Or Bond (1031); Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Event Description

Device report from synthes eu reports an event in the (b)(6) as follows: it was found that the zipfix instrument would not tension the implant.It is believed that this was due to a loosened screw.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Report is for one (1) unknown zipfix device.Device is an instrument and is not implanted / explanted.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

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.A product development investigation was performed for the subject device (part number 03.501.080, application instrument for sternal zipfix, lot number 7965113).The investigation has shown that the upper screw, which is connected to the operating lever, is unscrewed/missing as complained.The review of the production history revealed that this instrument was manufactured in june 2012 according to the specifications.No manufacturing related issues that would have contributed to this complaint were found.The assembly process at the time of manufacturing required that these screws are secured with an adhesive.The exact cause of this occurrence cannot be determined; it can be assumed that wear and tear and/or continuous stress, which the operating lever is subjected to, might have promoted the screw loosening.This instrument was subjected to some design and drawing changes including these specific screws which were replaced by cylinder pins as part of the design change.The new generation of this instrument has been available since oct 2012.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.Device history review: manufacturing location: (b)(4) - manufacturing date: june 27, 2012 no non-conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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.

Event Description

Update: it was reported that the loosened screw prevented the instrument from tightening the zipfix implants.Several attempts reportedly occurred before the facility decided to report the event.It is unknown when the events occurred and how many patients were involved.

• Brand Name: APPLICATION INSTRUMENT FOR STERNAL ZIPFIX
• Type of Device: CERCLAGE FIXATION
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf PA CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4894984
• MDR Text Key: 6541971
• Report Number: 2520274-2015-14817
• 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,company representati
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/25/2015

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 Catalogue Number: 03.501.080
• Device Lot Number: 7965113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2015
• Initial Date FDA Received: 07/07/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2012
• 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