MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Necrosis (1971)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown device/unknown lot.Part and lot number are unknown; udi number is unknown.Date of implantation is an unknown date between 2004 and 2006.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: jöckel, ja., brunner, a., thormann, s.And babst, r.(2010), elastic stabilisation of proximal humeral fractures with a new percutaneous angular stable wxation device (buttonfix®): a preliminary report, archives of orthopaedic and trauma surgery, vol.130(11), pages 1397-1403 (switzerland).The purpose of this study is to present a preliminary report of the radiological and clinical outcome after minimally invasive stabilization of selected proximal humerus fractures with buttonfix system and to compare the result with data in the literature.Between 2004 and 2006, a total of 17 patients (6 male and 11 female) with a mean age of 69 years (range, 16-89 years) were treated with buttonfix system (synthes, oberdorf, switzerland).The buttonfix system consists of a poly-ether-ether-ketone (peek) plate with four (4) holes and four (4) k-wires.Follow-up examinations took place 3, 6, and 12 weeks postoperatively and after a mean final follow-up of 18 months (range, 12-20 months).The following complications were reported: an (b)(6) year-old male patient showed radiological signs of avascular necrosis at the final follow-up.This patient achieved a constant-murley score of 23 points and a dash score of 67.5 points.The patient was satisfied with the operative result and refused any revision surgery.4 patients revealed minor valgus replacement (mean head-to-shaft angle, 152.5; range 150-155).1 patient underwent unplanned revision surgery due to early secondary fracture dislocation.This report is for an unknown synthes buttonfix system plate.This is report 1 of 4 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.510k: this report is for an unknown buttonfix plate/unknown lot.Part and lot number are unknown; udi number is unknown.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.

• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8351054
• MDR Text Key: 136602724
• Report Number: 8030965-2019-61137
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR