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

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

Patient Problems Muscular Rigidity (1968); Necrosis (1971); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients all information is provided in the article.This report is for an unknown plate/screw construct/unknown lot.Part and lot number 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

This report is being filed after the review of the following journal article: ahrend, m.D., et al.(2021), radiographic parameter(s) influencing functional outcomes following angular stable plate fixation of proximal humeral fractures, international orthopaedics, vol.Xx, pages 1-8 (switzerland) the primary aim of the study was to compare radiographic measurements between the injured and the contralateral, uninjured shoulder.The secondary aim was to correlate these radiographic parameters with post-operative shoulder function.A total of 58 patients (26 males abd 32 females with a mean age of 55.6 ± 14.4 years (range: 17.7 to 101.3 years, age at surgery) with proximal humeral fractures were treated with angular stable plate fixation.The implants used were an angular stable plate (philos® plate, depuy synthes, west chester, pennsylvania, usa or non-contact bridging plate, zimmer, germany gmbh, freiburg, deutschland, or 4.5- mm t-plate (stratec medical, oberdorf, schweiz).All patients were followed up at least six years.The article did not specify which of the devices were being used to capture the following complications: 43 patients died.1 patient had surgical site infection.4 patients showed necrosis of the humeral head.6 patients had screw perforations.2 patients caused by the necrosis of the humeral head.12 patients had joint stiffness or impigement following surgery.12 patients showed a satisfying or poor outcome.This report is for an unknown synthes philos plate.A copy of the literature article is being submitted with this medwatch.This report is for one (1) unknown plate/screw construct.This is report 3 of 3 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PHILOS PLATE/SCREWS
• Type of Device: PLATE, 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: 11961255
• MDR Text Key: 267227536
• Report Number: 8030965-2021-04695
• 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: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• 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: 05/14/2021
• 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