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

Catalog Number 03.501.080

Device Problem Mechanical Jam (2983)

Patient Problem No Patient Involvement (2645)

Event Date 09/19/2017

Event Type  malfunction  

Manufacturer Narrative

No patient involvement was reported.Device is an instrument and is not implanted/explanted.Subject device has been received and is currently in the evaluation process.The returned device was forwarded to sustaining engineering for investigation.2nd generation instrument design, with some expected visual evidence of longer use on the trigger component.No design related root cause has been identified on the returned instrument.The instrument functions as per the design intent.Therefore, the complaint is closed by sustaining engineering as invalid.Note: the potential root cause of the device failure based on the device condition as received could be related to the not performed lubrication during the clinical reprocessing.Dhr review was completed.Manufacturing location: (b)(4).Manufacturing date: 01.Dec.2015.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.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.

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported the application instrument for sternal zipfix is stuck.No patient involvement was reported.This report is for one (1) application instrument for sternal zipfix.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Pia investigation was completed.The investigation summary indicates that: it was found that the returned instrument from this complaint is fully functional, as per the design intent.It was noted that the instrument was returned `not lubricated` as per the clinical reprocessing instructions.This may have been the root cause why the instrument did not function as expected in the surgery.The complained instrument has been forwarded to the responsible trauma sustaining manager for a functional test.We are now in the receipt of the investigation result.It was found that the returned instrument from this complaint is fully functional, as per the design intent.It was noted that the instrument was returned `not lubricated` as per the clinical reprocessing instructions.This may have been the root cause why the instrument did not function as expected in the surgery.The potential root cause of the device failure based on the device condition as received could be related to the not performed lubrication during the clinical reprocessing.No product fault could be detected.The design and clinical risk management (dcrm) document was reviewed and found to adequately address the harm of this complaint condition.No design related root cause has been identified on the returned instrument.The instrument functions as per the design intent.Therefore, the complaint is invalid.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.

• 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: 7047116
• MDR Text Key: 93306147
• Report Number: 3003875359-2017-10565
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 07611819418424
• UDI-Public: (01)07611819418424(10)9742168
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• 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: 9742168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2015
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1