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

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

Patient Problems Arthritis (1723); Osteolysis (2377)

Event Type  Injury  

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device is not expected to be returned for manufacturer review/investigation.Product was not returned.Device history records review could not be completed without lot number.Based on the information available, it has been determined that no corrective and 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: lopiz, y.Et al (2018), complications with the clavicle hook plate after fixation of neer type ii clavicle fractures, international orthopaedics, pages 1-8 (spain).The purpose of this retrospective study is (1) to investigate the complication rate and long-term clinical and radiological outcomes of hook-plate fixation for distal neer type-ii clavicle fracture, (2) to compare the outcomes between iia/iib subtypes, (3) to determine whether hook plate fixation could induce rotator cuff tear by dynamic musculoskeletal ultrasound.Between 2011 and 2016, a total of 24 patients (20 male and 4 female) with a mean age of 42.5±15.6 years (range, 18-71 years) were included in the study.Fracture fixation was fixed using unknown synthes ao hook locking compression plate (depuy synthes, oberdorf, switzerland).The plate is a precountered stainless steel, dynamic compression available from 2-5 holes and with 3 different hook depths (12, 15, and 18 mm).The mean follow-up was 40.7±15.4 years (range, 24-74 months).The following complications were reported as follow: a (b)(6) year-old had a supraspinatus tendon tear on ultrasound evaluation.3 male cases (2 with diaphyseal 2-hole plates and 1 with diaphyseal 3-hole plate) had implant failure due to medial hardware mobilization at an average post-operative time of 3.2 weeks.The hardware displacement did not affect fracture reduction, so the 3 cases were treated maintaining the hardware until fracture union.All of them had a 15-mm-deep hook plate, and the fracture types were iia in 2 cases and iib in case.Another complication was a peri-implant fracture that needed additional surgery with a longer plate synthesis appropriate surgical reconstruction method remains controversial.1 case of subacromial impingement in the last follow-up functional evaluation after implant removal.1 patient had non-union with a constant score of 94.9 cases of acromioclavicular joint arthritis which was present at the time of fractures in 4 cases related to acromioclavicular joint at final follow-up.8 out of 9 patients had no symptoms related to the acromioclavicular joint.3 cases of subacromial osteolysis was present at final follow-up not related to age, gender, fracture pattern or implant characteristics.This report is for an unknown plate.This is report 5 of 6 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.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

Update: it was reported that there were no mentions of any death in particular or any relationship to the plate implant or procedure, thus any potential death can be disassociated from the use of the synthes clavicle hook plate.

• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8219455
• MDR Text Key: 132206107
• Report Number: 8030965-2019-59472
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• 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: 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2019
• 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: 02/22/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention