MAUDE Adverse Event Report: SYNTHES GMBH RIA 2 BONE HARVESTING KIT L520; REAMER

Catalog Number	03.404.000S
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Additional narrative: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found that the long aspiration tube of the ria 2 bone harvesting kit l520 was bent from the middle.Additionally the distal end was heavily deformed.The sleeve barre was broken and remains inside the manifold with barbs.The proximal coupling receiver was heavily deformed.The aspiration tube short and the colder fitting male were also retuned and it was found that were slightly deformed.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined based on the evidence provided.A dimensional inspection was unable to be performed due to the post-manufacturing damage.A functional test was unable to be performed due to the post-manufacturing damage.The overall complaint was confirmed as the observed condition of the ria 2 bone harvesting kit l520 would have contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Dimensional inspection: n/a device history part# 03.404.000s lot # 46663p2 manufacturing site: depuy synthes products, inc supplier: (b)(4).Release to warehouse date: 03 dec 2024 expiration date: 01 dec 2026 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
It was reported that an incident occurred during a graft harvesting procedure via the ria2 system.The approach procedure was properly followed, with the ria inserted almost in the axis of the femoral shaft.The problem occurred during the first drilling with the smallest diameter 10mm drill head.The diameter of the barrel was at least 10.5mm so there was no problem accessing the ria.It is during the removal of this head the fins broke inside the patient, a short distances from the femoral neck, requiring the surgeon to use laparoscopic forceps to recover the pieces.The surgery was delayed by about half an hour.It was also noticed shrinkage of the outer plastic at the end of the ria requiring to use a second ria2.The rest of the procedure was consistent with usage and recovered 60cc of quality graft.The patient is currently doing well; however, he required 6 blood bags due to significant perioperative bleeding.There has been no additional surgical intervention.Additional information received states that "during the operation (filling in the bone cavity of the left femoral shaft), the surgeon used equipment to loan the ria 2 kit requested during the programming of the patient in the operating room.The salesperson is present in the room at the request of the surgeon for technical assistance.The ria 2 kit is used to take bone grafts here at the level of the femoral diaphysis.When the device is withdrawn from the patient's shaft, the surgeon observes that the reamer head is not complete, that fins are missing and that they are in the patient.The salesperson also notes shrinkage of the outer plastic at the end of the ria 2.An additional 30 min is required for the surgeon with specific equipment available in the operating room to recover the pieces.In order to continue the operation, the use of a second ria 2 kit is then necessary in order to recover the bone graft.Second kit that we had also received upon receipt of the loan.The operation can therefore continue.The use of the second kit was effective and allows the surgeon to finish the operation.Incident that leads to additional operating time leading to an increase in operating time in a fragile septic patient.Lengthening of anesthetic time in a fragile patient.Increase in the risk of infection by increasing the operative time.".

• Brand Name: RIA 2 BONE HARVESTING KIT L520
• Common Device Name: REAMER
• 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: 22506210
• Report Number: 8030965-2025-07133
• Device Sequence Number: 15778844
• Product Code: HTO
• UDI-Device Identifier: 10886982274236
• UDI-Public: (01)10886982274236(17)261201(10)46663P2
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K993335
• 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

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: 03.404.000S
• Device Lot Number: 46663P2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2024
• 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