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

Catalog Number	03.404.000S
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2025
Type of Reportable Event	Malfunction
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.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
During surgery the ria system hose presents failures since the tip where the hose connects to the ramer breaks causing it to stop working properly, which is why it is necessary to unclog another ria system.In addition to this, the doctor reports that the ria heads were advancing with great difficulty through the medullary canal, which makes it difficult to take the graft, it should be clarified that the system was mounted correctly and it was checked that everything was well connected in addition to doing the previous steps of the technique before introducing the ria into the medullary canal, at the end of the surgery the doctor informs that only one ria kit can be charged, arguing that the one that presented the novelty is a product failure and that for this reason the desired amount of graft could not be extracted and does not authorize the inclusion of the ria system kit within the expense, in addition to this, the head of the sterilization center indicates that it is not the first time that there have been problems with this system.The surgery was ultimately completed successfully, without any harm to the patient or disruption to the surgical time.
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: photo investigation: the product was not returned to medtech orthopaedics , 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 consist with a random component failure that may have been caused by exposure to unintended force.The provided evidence was not sufficient to confirm the reported event of unable to assemble/disassemble and will not seat/advance.Functionality issues cannot be evaluated through a photo investigation.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, the ria 2 bone harvesting kit 520mm sterile has broken because of cause trace to 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 (dhr): part: 03.404.000s.Lot no: 54936p8.Release to warehouse date: 07 feb 2025.Expiry date: 1 feb 2027.Manufacturing site: werk selzach.Supplier: (b)(6).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): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 21899643
• Report Number: 8030965-2025-03990
• Device Sequence Number: 4009047
• Product Code: HTO
• UDI-Device Identifier: 10886982274236
• UDI-Public: (01)10886982274236(17)270201(10)54936P8
• 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,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: 03.404.000S
• Device Lot Number: 54936P8
• 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: 03/27/2025
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2025
• 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