MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH HUMERUS BLOCK; PLATE, FIXATION, BONE

Catalog Number 291.600S

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

Patient Problems Necrosis (1971); Thrombosis (2100); Non-union Bone Fracture (2369); Joint Dislocation (2374)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Device is not distributed in the united states, but is similar to device marketed in the usa.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.

Event Description

This report is being filed after the review of the following journal article: bogner, r.Et al (2016), minimally invasive treatment of displaced proximal humeral fractures in patients older than 70 years using the humerusblock, biomed research international, vol.2016, pages 1-6, http://dx.Doi.Org/10.1155/2016/6451849 (austria).The aim of this retrospective single centric study is to analyze the technical feasibility as well as clinical and radiological outcome after minimally invasive, percutaneous reduction and internal fixation (crif) of displaced phf in the elderly using the semirigid humerusblock device.Between january 2005 to december 2010, a total of 207 patients with a mean age of 79.8 years (range, 70¿101) were included in the study.Surgery was performed using a humerusblock device (synthes, oberdorf, switzerland) in 232 fractures while for the rest of the patients, a competitor device was used.Radiological follow-up was completed at 2, 4, and 6 weeks postoperatively and at final follow-up.Only 129 patients (24 male and 105 female) could be evaluated clinically and radiographically after a mean of 22.9 months (range, 6¿79) postoperatively.The following complications were reported as follows: 43 patients died.10 patients had secondary dislocation.In four of those patients, revision surgery, using the humerusblock again was performed.In four patients rsa, in one patient intramedullary nail, and in one patient an angular stable plate was used for revision surgery.9 patients had nonunion; in four of those patients surgical revision was performed (three rsa, one blade-plate).1 patient had superficial, postoperative wound-infection was treated conservatively with intravenous antibiotics.1 patient had deep vein thrombosis of the operated arm.8 patients had avascular necrosis of the humeral head necrosis.5 patients showed partial necrosis and 3 patients showed complete collapse of the humeral head.This is report 1 of 4 for (b)(4).This report is for an unknown synthes humerus block, a copy of the literature article is being submitted with this medwatch.

• Brand Name: HUMERUS BLOCK
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9676588
• MDR Text Key: 191015217
• Report Number: 8030965-2020-00886
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819274259
• UDI-Public: (01)07611819274259
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 291.600S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention