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

Catalog Number	UNK - CONSTRUCTS: PHILOS PLATE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Muscular Rigidity (1968); Necrosis (1971); Nonunion/Delayed-union Bone Fracture (2369); Muscle/Tendon Damage (4532)
Date of Event	08/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.D4: udi: as the catalog/model number was not provided, the (01) gtin is not available.
Event or Problem Description
This complaint is from a literature source.The following literature cite has been reviewed: nishant narayan gholap, valaparla dev manohar kiran, robin c raju, amar vishal.Study of functional outcome of philos plating in neer¿s type ii, iii, iv proximal humerus fractures in young adults and elderly patients.Int j acad med pharm 2025; 7 (4); 1018-1022.Doi: 10.47009/jamp.2025.7.4.194.(pubmed cite not available) objective/methods/study data: this study aims to evaluate the functional outcome and complication profile of philos plating in neer¿s type ii, iii, and iv proximal humerus fractures among young adults and elderly patients in a rural indian setting.From february 2022 to october 2024.A total of 39 patients with displaced proximal humerus fractures classified as neer¿s type ii (n=4; 10.25%), type iii (n=23; 58.97%), and type iv (n=12; 30.76%) were enrolled.The study population comprised 20 males (51.28%) and 19 females (48.71%), with a mean age of 54 years (range: 27¿80 years).All patients underwent open reduction and internal fixation (orif) with a philos plate through the standard deltopectoral approach.Screw placement, especially calcar screws, was meticulously planned under fluoroscopic guidance to ensure angular stability and prevent articular penetration.Functional outcomes at six months, assessed using the constant and murley scoring system.Lot, model and catalog number are not available, but the suspected depuy synthes device(s) possibly associated with reported adverse events: depuy synthes philos plate.Adverse event(s) and provided interventions possibly associated with unk - screws: philos (qty 2): (n=2) screw cut-out; underwent reoperation.Adverse event(s) and provided interventions possibly associated with unk - constructs: philos plate/screws (qty 6): (n=1) avascular necrosis (avn); underwent reoperation.(n=1) subacromial impingement; underwent reoperation.(n=1) superficial surgical site infection; managed conservatively with targeted antibiotics (n=2) delayed union consolidating by 16 weeks; no treatment reported.(n=1) severe shoulder stiffness; no treatment reported.
Additional 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.H11 additional narrative: added: d4 catalog.H6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.Investigation summary.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 if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNK - CONSTRUCTS: PHILOS PLATE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 24740838
• Report Number: 8030965-2026-02963
• Device Sequence Number: 9060579
• Product Code: HRS
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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
• Operator of Device: Health Professional
• Device Catalogue Number: UNK - CONSTRUCTS: PHILOS PLATE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/10/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown