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

Catalog Number 03.501.080

Device Problems Material Fragmentation (1261); Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.A device history record review was performed for the subject device lot.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.The subject device has been received and is currently in the evaluation process.A service and repair evaluation was also performed for the subject device.The repair technician reported a piece has broken off the cutting element.¿damaged component¿ is the reason for repair.The instrument is not repairable.The cause of the issue is unknown.The device was forwarded to synthes customer quality for additional evaluation.The results of the additional evaluation are pending completion.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 the sternal zipfix instrument was discovered to have one of its teeth chipped off.The issue was found during routine instrument inspection.There was no patient or surgical involvement.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

No service history review can be performed as part number 03.501.080 with lot number(s) 7831855 is a lot/batch controlled item.An additional manufacture date of this item is april 05, 2012.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed.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.

Manufacturer Narrative

Additional narrative: 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.

Manufacturer Narrative

An investigation summary was performed.The investigation of the complaint articles has shown that: one application instrument for sternal zipfix (part number 03.501.080, lot number 7831855) was received with the complaint category of ¿broken: procedural step unknown.¿ the complaint condition is confirmed as the device was received with the cutter (component number (b)(4)) on the cutter assembly broken off.The break is located such that the entire upper cutting projection is broken off and was not returned.Since it is unknown when and how the damage occurred a root cause could not be definitively determined.Review of the failure mode determined that the complaint condition is the result of force beyond the yield strength of the material.A break of this nature would require significant force and would not be expected when used as recommended.However, since it is unknown when and how the damage occurred, a root cause cannot be definitively determined.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition of the broken cutter.The design of the cutter and cutter assembly were determined to be suitable for the intended use when employed and maintained as recommended.This investigation summary is approved.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 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: 5517830
• MDR Text Key: 40935469
• Report Number: 3003875359-2016-10196
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2016
• 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: 7831855
• Other Device ID Number: (01)10887587010847(10)7831855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2012
• 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