MAUDE Adverse Event Report: SYNTHES GMBH UNK - SCREWS: LOCKING; SCREW,FIXATION,BONE

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

Patient Problems Muscular Rigidity (1968); Necrosis (1971); Malunion of Bone (4529); Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unk - screws: locking/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 as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The product was not returned.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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: li, j et al.(2021), stable osteosynthesis of cage in cage technique for surgical treatment of proximal humeral fractures, bmc surgery, volume 21:233, pages 1-8, ((b)(6)) this study presents a novel technique and clinical experience using a peek cage to fill the cavity under the humeral head and to provide a medial structural buttress in the treatment of displaced proximal humeral fractures.Peek cage locates in a ¿cage space¿ formed by locking screws of lcp.The purpose of this study is to report outcomes during a period between 1- and 4-years follow-up after surgical treatment with emphasis on the complication rate and function results.During the period of (b)(6) 2016 and (b)(6) 2019, 27 patients with displaced proximal humeral fractures who were treated by lcp with peek cage were included in the study.There were 14 males and 13 females.The patients were implanted with an unknown synthes locking compression plate proximal humerus plate with an unknown depuy spine concorde cage that was inserted through the lateral fracture window into the medial site of the humeral head fragment as both an indirect reduction tool and mechanical support for the prevention of varus displacement and deformity of the humeral head.Postoperatively, patients were immobilized in a sling, and immediate passive mobilization and pendulum exercises were encouraged 1 time per day.In addition, supervised physiotherapy was carried out and gradually ceased around 3 weeks, including a standard protocol of non-weightbearing exercise, active-assisted range of motion, and gentle passive range of motion.The forward elevation and abduction were limited to 100 degrees, and external rotation was limited to 30 degrees.Complications were reported: 1 patient had malreduction.1 patient had osteonecrosis with 24 months follow-up, but the patient was satisfied with the overall outcomes and without any revision surgery.1 patient had loss of reduction and without any further treatment.2 patients had stiffness.1 of whom declined additional treatment and the other 1 underwent arthroscopic release for stiffness.This report is for the unknown synthes locking compression plate proximal humerus plate and screws.This report is for (1) unk - screws: locking this report is 2 of 2 for (b)(4).

• Brand Name: UNK - SCREWS: LOCKING
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12059603
• MDR Text Key: 267646072
• Report Number: 8030965-2021-05296
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• 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: 05/31/2021
• 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