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

Catalog Number 03.501.080

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.A review of the device history records has been requested.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The review of the service order form from the affiliate in (b)(4) indicates the device was sent in for service for the following: device is not functioning properly.Further to this the service technician identified the following: update / upgrade and the technician noted all m3 screw side and the nut were glued, recall, otherwise found no errors the problem of the customer could not be traced.No further information is available from the affiliate.There were no injuries, patient user involvement or surgery delay or need for additional medical intervention reported.If any additional information should become available, this notification will be updated accordingly.(b)(4).

Manufacturer 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

Manufacturing date: november 27, 2015.Manufacturing location: (b)(4).Business group: (b)(4).Device part 03.501.080, lot 9742690 is a batch number controlled product, therefore no service history record review is possible.No non-conformance reports, rework or other relevant quality notifications were referenced in the device history record.Review of the device history record(s) (dhr) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The conclusion of the dhr review is that the final products manufactured in the production processes relevant to the device in the current complaint met inspection requirements, certification test values, and acceptance criteria.A service evaluation was completed: the review of the service order form from the affiliate indicates the device was sent in for service for the following: device is not functioning properly.Further to this the service technician identified the following: update / upgrade.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.The technician noted that all screw sides and the nut were glued; otherwise found no errors the problem of the customer could not be traced.The device has been serviced and functional testing has been performed in accordance with the service manual.The service technician identified the probable root cause as undetermined - not determinable.Based on the information received and reported on the complaint file, no issues were identified during review of the device history record, and the fact that the kind of failure reported is due to normal wear.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 OBERDORF; eimattstrasse 3; oberdorf CH443 6; SZ CH4436
• Manufacturer (Section G): SYNTHES OBERDORF; eimattstrasse 3; oberdorf CH443 6; SZ CH4436
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5612780
• MDR Text Key: 44581944
• Report Number: 8030965-2016-13475
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/31/2016

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: 9742690
• Other Device ID Number: (01) 07611819418424(10)9742690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/31/2016
• Initial Date FDA Received: 04/27/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/28/2016; 05/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2015
• 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