MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: 3.5 MM LCP EXTRA-ARTICULAR DISTAL HUMERUS PLATE/SCREWS; PLATE, FIXATION ,BONE

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

Patient Problems Pain (1994); Discomfort (2330)

Event Date 05/16/2022

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.Pma/510k: this report is for an unknown device/unknown lot.Part and lot numbers are unknown; udi number is unknown.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.

Event Description

Device report from (b)(6) reports an event as follows: this report is being filed after the review of the following journal article: shin s.J., kwak j.W., and sohn h.S.(2022), comparison between anterior and posterior plating systems in extra-articular distal-third diaphyseal humeral fractures, international orthopaedics, vol.Xx (xx), pages 1-8 (korea, south).The purpose of this retrospective study of a prospectively collected data was to compare the clinical and radiographic outcomes between anterior plating with philos and posterior plating with eadhp for the treatment of acute displaced extra-articular distal-third diaphyseal humeral fractures.A total of 46 patients (30 male and 16 female) with a mean age of 38.8 ± 18.4 years old (range, 15¿80 years) were included in the study.Among them, 24 patients (16 male and 8 female; mean age of 43.3 ± 17.4 years) underwent anterior plating with the modified use of proximal humeral internal locking system (philos, synthes, paoli, pa) between march 2012 to july 2017 and 22 patients (14 male and 8 female; mean age of 33.5 ± 18.6 years) were treated with open reduction and posterior plating with an extra-articular distal humerus plate (eadhp, synthes, paoli, pa) between august 2017 and july 2020.The mean follow-up period was 13.7 ± 7.8 months (range, 12¿41 months).The following complications were reported as follows: philos group: in 4 patients without any plate-related symptoms, surgery for plate removal was performed just because of patient requests.A 64-year-old male patient had nonunion and underwent bone grafting.Bone union was achieved 12 months after the second operation.Extra-articular distal humerus plate group: 17 patients (9 male and 7 female) had discomfort in daily life, pain when the elbow hit hard objects, and cosmetic issues due to plate protrusion among these, 9 patients had plate removal upon patient request.A 24-year-old male patient had postoperative radial nerve palsy.He showed complete recovery of radial nerve palsy at nine weeks after surgery.This report is for a unk - plates: 3.5 mm lcp extra-articular distal humerus plate.This is report 1 of 3 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: 3.5 MM LCP EXTRA-ARTICULAR DISTAL HUMERUS PLATE/SCREWS
• Type of Device: PLATE, FIXATION ,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA ; 3035526892
• MDR Report Key: 14982327
• MDR Text Key: 295683711
• Report Number: 8030965-2022-04733
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2022
• 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): Other; Required Intervention