MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH APPLICATION INSTRUMENT FOR STERNAL ZIPFIX; CERCLAGE FIXATION

Catalog Number 03.501.080

Device Problem Device Operational Issue (2914)

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

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.No known patient involvement.It is unknown when the malfunction occurred.Device is an instrument and is not implanted/explanted.Device has been returned for investigation.Reporter telephone number is not available for reporting.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 that tensioning mechanism was not functioning.It is unknown how or when the malfunction was discovered.It was unknown if there was patient involvement.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.A device history record review was performed for the subject device: part number: 03.501.080.Synthes lot number: 9893634.Release to warehouse date: 09.Jun.2016.Manufacturing site: hägendorf.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.A product development investigation was performed for the subject device: the investigation has shown that the present application instrument indeed, upon release of the squeeze lever, it doesn't get back to initial position.The ¿not lubricated¿ condition of the returned device may have been the root cause why the instrument did not tension as expected in the surgery.A functional test was re-performed with the returned instrument after lubrication, as per the surgical technique guide.Implant used for functional test 08.501.001.20s.The instrument 03.501.080 functions as intended, including tensioning and cutting mechanisms.The review of the device history records showed that this instrument was manufactured in june 2016 according to the specifications.The articles conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities reported.The investigation found no manufacturing related issues that would have contributed to this complaint condition.We can only assume that a handling failure in reprocessing caused this occurrence; a material or manufacturing related issue can be excluded.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7313252
• MDR Text Key: 101706748
• Report Number: 8030965-2018-51712
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 07611819418424
• UDI-Public: (01)07611819418424(10)9893634
• Combination Product (y/n): N
• PMA/PMN Number: K110789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2018
• 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: 9893634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2018
• Date Manufacturer Received: 04/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1