MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: PHILOS; PLATE,FIXATION,BONE

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Necrosis (1971); Insufficient Information (4580)

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: claro, r.Et al (2023), comparative analysis of proximal humerus fracture management in elderly patients: complications of open reduction and internal fixation by shoulder surgeons and non-shoulder surgeons: a retrospective study, clin shoulder elbow xx (xx), pages 1-7 (portugal).The study aimed to assess the occurrence of complications in elderly patients with phf treated surgically using orif with a locking plate and to investigate the potential differences between patients treated by shoulder surgeons and non-shoulder surgeons.Between january 1, 2011, and december 31, 2021, a total of 83 patients (16 male and 67 female) with a mean age of 77 years were included in the study.These patients underwent open reduction and internal fixation using the philos locking plate (depuysynthes) for proximal humeral fractures.Follow-up consultations included radiographic assessments at 4 weeks, 3 months, 6 months, and 1 year, followed by annual assessments (mean follow-up is 537 days).The following complications were reported as follows: - (n=13) implant failure; - (n=4) avascular necrosis.This report is for an unknown synthes philos locking plate.A copy of the literature article is being submitted with this report.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: 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.

• Brand Name: UNK - PLATES: PHILOS
• 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 19380 ; 3035526892
• MDR Report Key: 19132472
• MDR Text Key: 340452750
• Report Number: 8030965-2024-05217
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 04/05/2024
• Initial Date FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention