MAUDE Adverse Event Report: SYNTHES GMBH RETROGR FEM NAIL ADV - RFN-ADV Ø14 L 280; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	04.233.428S
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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: 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
It was reported that on (b)(6) 2025, the patient underwent an unknown surgery for supracondylar femoral fracture with the nail.Since the medullary cavity was wide, the nail was inserted manually without reaming, but only at the end, the nail was inserted to the indicated position by lightly hammering several times.After that, the distal part was fixed with four screws, and when the proximal part was checked from the front by fluoroscopy, a crack-like line was seen from the tip of the nail, but it was not possible to be certain, so the surgery was continued.When the circular part of the ap hole was drilled and the screws were inserted, the cortical bone in front was raised, and a fracture was confirmed.Therefore, all the nails and screws were removed, replaced with a 320mm nail, and four distal screws and two proximal screws were inserted again, and the surgery was completed successfully with no delay.After the surgery, the surgeon and the sales rep discussed the causes of this incident, including a mismatch between the femoral lordosis and the nail shape, which put stress on the anterior cortical bone (including hammering), the tip was inserted in a forward direction due to the effect of entering too rigidly into the medullary cavity, the bone quality of the (b)(6) year-old elderly person is fragile, and it is possible that the fracture was present from the beginning.No further information is available.
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: b5, d10 (concomitant).H3, h6: 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 device history review (dhr): part # 04.233.428s.Lot # 34499p3.Manufacturing site: depuy synthes products, inc.Supplier: (b)(4).Release to warehouse date: 23 sep 2024.Expiration date: 01 sep 2029.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified 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
Additional information received states that there were no allegations against the screws.

• Brand Name: RETROGR FEM NAIL ADV - RFN-ADV Ø14 L 280
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 22360740
• Report Number: 8030965-2025-06634
• Device Sequence Number: 20987934
• Product Code: HSB
• UDI-Device Identifier: 10886982291110
• UDI-Public: (01)10886982291110(17)290901(10)34499P3
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K233696
• 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,Company Representative
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 04.233.428S
• Device Lot Number: 34499P3
• 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: 06/10/2025
• Supplement Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: NAIL DISTAL LOCKING.; UNK - SCREWS: NAIL DISTAL LOCKING.; UNK - SCREWS: NAIL DISTAL LOCKING.; UNK - SCREWS: NAIL DISTAL LOCKING.; UNK - SCREWS: NAIL PROXIMAL LOCKING.; UNK - SCREWS: NAIL PROXIMAL LOCKING.
• Patient Sex: Unknown