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

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

Patient Problem No Code Available (3191)

Event Date 11/07/2017

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown synthes humerusblock/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4): the patient continued to experience subluxation postoperatively.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: carbone, s.Et al (2018), humeral head inferior subluxation in proximal humerus fractures, international orthopaedics, vol.42(4), pages 901-907 (italy).The objectives of this retrospective observational study are: to propose a simple and reliable radiologic method for detecting static inferior subluxation of the humeral head and to calculate the relative intra- and inter-observer reliability; to evaluate the presence of static inferior subluxation pre- and post-surgery; and to determine if it may present a precocious sign of screw joint perforation.Between june 2012 and december 2015, a total of 150 patients were included in the study.These patients were divided into two groups: semi-rigid fixation (humerusblock, synthes, oberdorf, switzerland) (group i) consisted of 105 patients (31 male and 71 female) with a mean age of 68 years (range, 49-87 years) and rigid fixation (proximal humeral internal locking system (philos) locking plate, synthes, oberdorf, switzerland) (group ii) consisted of 45 patients (22 male and 23 female) with a mean age of 65 years (range, 32-69 years).Clinical evaluation was recorded at 12 months of follow-up using constant score by a researcher not involved in surgery and follow-ups.The following complications were reported as follow under semi-rigid fixation (humerusblock, synthes, oberdorf, switzerland) (group i): 13 cases had inferior subluxation at 3 months follow-up.4 cases showed persistent inferior subluxation at 12 months follow-up.4 cases had pin or screw articular perforation in group 1 confirmed with ct scans these four patients had complete hardware removal at 3 months.The following complications were reported as follow under semi-rigid fixation rigid fixation (proximal humeral internal locking system (philos) locking plate, synthes, oberdorf, switzerland) (group ii): 9 cases had inferior subluxation at 3 months follow-up.3 cases showed persistent inferior subluxation at 12 months follow-up.2 cases had pin or screw articular perforation in group 2 confirmed with ct scans these two patients had removal of the penetrating screws at 3 months.3 cases had pin or screw articular perforation in group 2 confirmed with ct scans at 12 months.This report is for the patients who continued to experience subluxation postoperatively.This report is for an unknown synthes humerus block.This is report 2 of 5 for (b)(4).

• 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: 8198753
• MDR Text Key: 131473775
• Report Number: 8030965-2018-59266
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2018
• 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