MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM VA PPFX GT RING ATTCHMT PLATE/SMALL/RIGHT; PLATE, FIXATION, BONE

Catalog Number	02.221.100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
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.Additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
This complaint is from a data use agreement (dua).The dua summarizes 13 patients that were implanted with va-lcp periprosthetic proximal femur plating system.Implantation was between (b)(6) 2021 to (b)(6) 2024 at university hospital cleveland.All patients had the implants placed for treatment of proximal periprosthetic femur fractures.Patient id #(b)(6) (70-year-old female) ¿ required surgical debridement 4 weeks post operation due to infection secondary to a hematoma after anti-coagulation therapy.No implants were removed.The patient went on to achieve bone union at final follow up and was ambulatory with a cane.The hematoma and infection were noted to be related to the procedure.This report is for a 3.5mm va ppfx gt ring attchmt plate/small/right.

• Brand Name: 3.5MM VA PPFX GT RING ATTCHMT PLATE/SMALL/RIGHT
• Common Device Name: 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: 20169205
• Report Number: 8030965-2024-10931
• Device Sequence Number: 15516529
• Product Code: HRS
• UDI-Device Identifier: 10886982275998
• UDI-Public: (01)10886982275998
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K210205
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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
• Operator of Device: Health Professional
• Device Catalogue Number: 02.221.100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female