MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - CONSTRUCTS: PLATE/SCREWS; PLATE, FIXATION, BONE

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

Patient Problems Necrosis (1971); Tissue Damage (2104); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown philos construct/ 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).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: biermann, n.Et al.(2020), glenohumeral joint lavage does not affect clinical outcomes in open reduction and internal fixation of displaced intracapsular proximal humeral fractures: a prospective, randomized, double-blinded trial, journal of shoulder and elbow surgery, vol.29, pages 1758-1764, (germany).The aim of this trial was to determine the effect of intraoperative glenohumeral joint lavage on rom and functional outcomes after open reduction and internal fixation of displaced intracapsular proximal humeral fractures.Between january 2016 and april 2018, 72 patients (mean age: 65.2 +/ 16.3 years) with a displaced intracapsular proximal humeral fracture were treated by open reduction and internal fixation using an anatomically precontoured locking plate (philos; depuy synthes gmbh, oberdorf, switzerland).Patients were randomized to either locked plating followed by intraoperatively performed glenohumeral joint lavage (group l, n = 36; 19 females and 12 males) or locked plating without the lavage (group nl, n = 36; 22 females and 9 males).The postoperative study protocol included a prospective examination of functional outcomes at 6 weeks, 3 months 6 months, and 12 months of follow-up.The following complications were reported as follows: 3 patients deceased within the 1-year study period due to causes unrelated to the fracture treatment 3 patients had avascular necrosis.1 patient had secondary displacement.1 patient had adhesive capsulitis.1 patient had secondary displacement with articular screw perforation.This report is for an unknown synthes philos construct.It captures the reported avascular necrosis, secondary displacement, adhesive capsulitis.This is report 1 of 2 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PLATE/SCREWS
• 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: 10770940
• MDR Text Key: 216875365
• Report Number: 8030965-2020-08476
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• 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: 10/06/2020
• 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