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

Catalog Number	02.221.103S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2026
Type of Reportable Event	Malfunction
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.H11 additional narrative: d4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.
Event or Problem Description
It was reported during a ppfx surgery that the va locking ppfx greater trochanter ring could not be threaded onto the proximal femur plate.Attempts to engage a second ring plate also failed, resulting in the inability to implant any ring plate.The event led to a significant delay of approximately 25 minutes, and the fracture could not be fixed as required.There was reported patient harm, but no additional medical or surgical intervention or extended hospitalization was necessary.

• Brand Name: 3.5MM VA PPFX GT RING ATTCHMT PLATE/LARGE/LEFT/STERILE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 25113895
• Report Number: 8030965-2026-04351
• Device Sequence Number: 9326050
• Product Code: HRS
• UDI-Device Identifier: 10886982276049
• UDI-Public: (01)10886982276049(17)350801(10)71704P6
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 02.221.103S
• Device Lot Number: 71704P6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2026
• Supplement Date Received by Manufacturer: 05/18/2026; 06/09/2026
• Initial Report FDA Received Date: 05/07/2026
• Supplement Report FDA Received Date: 05/26/2026; 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/06/2025
• 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
• Patient Sex: Unknown