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 Necrosis (1971); Nerve Damage (1979); Non-union Bone Fracture (2369); Post Operative Wound Infection (2446); Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown constructs: philos plate/screws/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 synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: van de wall1, b.J.M., et al.(2020), results of plate fixation for humerus fractures in a large single center cohort, archives of orthopaedic and trauma surgery, vol.140, pages 1311-1318 (switzerland) this study aims to describe the results of plate fixation in one of the largest single-center cohorts that employs plate fixation as the golden standard.Additionally, risk factors related to a negative outcome were identified.Between january 2010 and december 2017 a total of 102 patients (56 males and 46 females with a mean age of 20 years) underwent plate fixation using either a philos (for proximal shaft fractures) or narrow lcp 4.5-mm/3.5-mm (midshaft or distal fractures) plate.Patients were followed up for a median of 12 months (range 3¿59).The following complications were reported as follows: 1 patient developed a deep surgical site infection following the plate fixation of a gustilo grade-ii shaft fracture.This patient was treated with antibiotics.The implant had to be removed due to persistent infection after 3 months.A second plate fixation was performed after a 6-week interval after which the fracture healed uneventfully.4 patients developed a non-union.Three of these four patients with non-unions had a revision of the implant with the addition of cancellous bone after which the fracture healed.One patient was treated conservatively due to psychiatric comorbidities and poor compliance.2 patients developed partial nerve palsy postoperatively.1 patient had persistent radial nerve palsy.9 patients had partial nerve palsy during follow-up.Contusion of the nerve was reported in three patients.No additional treatment for the nerve was performed.6 patients had implant removal due to nonunion.3 patients had implant removal due to loss of reduction within 6 weeks postoperatively.3 patients had implant removal due to infection.1 patient had implant removal due to humeral head necrosis.1 patient had implant removal due to partial nerve palsy postoperatively.This report is for an unknown philos.This is report 1 of 2 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: 11886720
• MDR Text Key: 266421477
• Report Number: 8030965-2021-04307
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• 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: 05/18/2021
• 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