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 Pulmonary Embolism (1498); Unspecified Infection (1930); Muscular Rigidity (1968); Nerve Damage (1979); Muscle/Tendon Damage (4532)

Event Date 05/10/2023

Event Type  Injury  

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: d1, d2, d3, d4, g4-510k: this report is for an unknown constructs: philos plate/screws/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.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.

Event Description

This report is being filed after the review of the following journal article: dewarrat, a.Et al (2023), comparison of the alps and philos plating systems in proximal humeral fracture fixation ¿ a retrospective study, bmc musculoskeletal disorders vol.24 (no.371), pages 1-11 (switzerland).The objective of the study was to review the clinical outcome and complications of the anatomic locking plate system (alps) and compare it to the proximal humeral internal locking system (philos).Between february 2017 and september 2018, a consecutive series of 20 patients (11 male and 9 female) with a mean age of 52 years, treated with anatomic locking plate system (alps) (biomet) for proximal humerus fracture were retrospectively compared to 27 patients (16 male and 11 female) with a mean age of 58 years who were treated with proximal humeral internal locking system (philos) (depuy-synthes) also for proximal humerus fracture between march 2015 and december 2016.Union, range of motion (rom) and complications were clinically and radiologically assessed at 6 weeks, 3, 6, 12 and 18¿24 months post-operatively.The following complications were reported as follows: - (n=4) secondary displacement - (n=2) avascular necrosis; (had implant removal) - (n=6) screw perforation; (5 of 6 had implant removal) - (n=3) subacromial impingement; (2 of 3 had implant removal) - (n=2) infection - (n=2) nerve palsy - (n=1) pulmonary embolus - (n=2) stiffness; (1 of 2 had implant removal) this report is for an unknown synthes constructs: philos plate/screws.A copy of the literature article is being submitted with this report.This is report 2 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: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 19124021
• MDR Text Key: 340351628
• Report Number: 8030965-2024-05178
• 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,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: 04/17/2024
• 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