MAUDE Adverse Event Report: SYNTHES GMBH RIA 2 BONE HARVESTING KIT 520MM STERILE; REAMER

Catalog Number	03.404.000S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure the extraction kit of the ria system is passed, the proper connections were made to pass the reamer and at the time of rhyming the medullary channel it was noticed that the yellow seal, the one that is responsible for not leaving the water, was melting.The specialist was informed to stop so it could be changed.It was then noticed that the blue plastic was also melting.For this novelty there was no discomfort on the part of the doctor.The doctor reports that he knew that the ria system was not indicated for this procedure but that he needed it to collect the pathology.The surgery was completed successfully, without affecting the patient and without alterations in the surgical times.
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.
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: the product was not returned to medtech orthopedics; however, photos were provided for review.The photo investigation revealed that ¿03.404.000s ria 2 bone harvesting kit 520mm sterile¿ has broken.The observed condition of the device was consistent with a component failure that may have been caused by exposure to unintended forces.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the ria 2 bone harvesting kit 520mm sterile would contribute to the complained device issue.Based on the investigation findings, ria 2 bone harvesting kit 520mm sterile was broken because of component failure, and 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 complaint condition.As part of medtech orthopedics 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.Device history review : part # 03.404.000s.Lot # 37840p6.Manufacturing site: werk selzach logistik.Release to warehouse date: 03.Oct.2024.Supplier: (b)(4).Expiration date: 01.Oct.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.

• Brand Name: RIA 2 BONE HARVESTING KIT 520MM STERILE
• 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: 22563741
• Report Number: 8030965-2025-07324
• Device Sequence Number: 3994271
• Product Code: HTO
• UDI-Device Identifier: 10886982274236
• UDI-Public: (01)10886982274236(17)261001(10)37840P6
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• 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 Expiration Date: 10/01/2026
• Device Catalogue Number: 03.404.000S
• Device Lot Number: 37840P6
• 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: 06/28/2025
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2024
• 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