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

Catalog Number	02.221.101
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2026
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.
Event or Problem Description
It was reported that va locking ppfx greater trochanter ring and 3.5 val great troch rng atch pl/lrg/rt and 3.5 val great troch ring attach pl/sm/lt were involved in an event.During a procedure to repair a fracture around a total hip, attempts to attach the small gt ring attachment plate to the va-lcp ppfx proximal femur plate were unsuccessful due to stripped screws on the gt ring attachment.Further attempts to remove screws from the large gt ring plate also resulted in stripped screws.All screws from the gt ring plates (four in total) were found to be stripped, preventing attachment.The procedure was completed without the gt ring attachment plate, resulting in a delay of approximately 10 minutes.There was no reported patient harm or consequence, and the patient outcome was good.
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: h3, h6: visual analysis of the returned sample revealed that va locking ppfx greater trochanter ring was found with the part number: 60335962 connecting screws stripped from the threads and stardrive feature.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.Properly handling and attention to the approved use of the device diminishes the risk of failure.A dimensional inspection for the va locking ppfx greater trochanter ring was not performed due to post manufacturing damage.A functional test was performed and the screw could no be connected properly to plate.The overall complaint was confirmed as the observed condition of the va locking ppfx greater trochanter ring would contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.There is no indication that a design or manufacturing issue has caused the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot.01/14/2026: dhr/shr review for this following part/lot combination conducted.Product code: 02.221.101-us.Lot number: 6401p94.Manufacturing date: 06/09/2023.Expiry date: n/a.No non-conformance / manufacturing irregularities were identified.Dhr for the following device conducted: product code: 02.221.180.Lot number: 2011p84.Manufacturing date: 12/14/2022.Expiration date: n/a (non-sterile).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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: d9.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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.H11 additional narrative: added: d10 if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 3.5MM VA PPFX GT RING ATTCHMT PLATE/SMALL/LEFT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• 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: 24143834
• Report Number: 8030965-2026-00717
• Device Sequence Number: 18391841
• Product Code: HRS
• UDI-Device Identifier: 10886982276148
• UDI-Public: (01)10886982276148(10)6401P94
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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: 02.221.101
• Device Lot Number: 6401P94
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/01/2026
• Supplement Date Received by Manufacturer: 02/05/2026; 02/11/2026; 02/13/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 02/09/2026; 02/13/2026; 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 3.5 VAL GREAT TROCH RING ATTACH PL/SM/LT; 3.5 VAL GREAT TROCH RNG ATCH PL/LRG/RT; CONNECSCR F/VA LOCKING PPFX GREATER TROC; CONNECSCR F/VA LOCKING PPFX GREATER TROC; CONNECSCR F/VA LOCKING PPFX GREATER TROC; CONNECSCR F/VA LOCKING PPFX GREATER TROC; VA LOCKING PPFX GREATER TROCHANTER RING
• Patient Sex: Unknown