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	09/27/2024
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 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) 2024, during a tibia infection washout, the metal portion of the ria gun handle disposable broke in several pieces while reaming.There was 10 minutes surgical delay.Processed with surgery and did the best for the patient.Procedure was successfully completed.The metal end of disposable broke.There was no patient consequences.
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 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 the fragments were removed intraoperatively.
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: b5, e1 (facility name).H6: photo investigation: the product was not returned to j&j medtech orthopaedics, however photos were provided for review.Visual analysis of the photo revealed the distal end of the tube assembly of the manifold was torn apart, therefore, the reported condition can be confirmed.Furthermore, it was observed a detached aspiration port and a reamer alongside other unknown surgical instrumentation.A complete potential cause cannot be determinate with available information.Properly handling and attention to the approved use of the device diminishes the risk of failure.Surgical technique.Ac was reviewed and the following relevant statements were found: precaution: never ream when there is no irrigation/aspiration.The irrigation/aspiration fluid cools the reamer head and removes bone marrow and morselized bone from the medullary canal.Fluid flow is crucial for proper system performance.Periodically check that the reaming aspirate is flowing through the tube and into the suction canister.If there is no material flow, stop reaming, turn off suction and retract the reamer head outside the patient to evaluate for obstructions in the flow path.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the ria 2 bone harvesting kit 520mm sterile 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.Device history review (dhr): manufacturing location: packaged, sterilized, and released by: monument.Release to warehouse date: 18-jul-2024.Expiration date: 30-jun-2026.Part number: 03.404.000s, ria 2 bone harvesting kit 520mm sterile.Lot number: 26263p0.Lot quantity: (b)(4).This lot met all dimensional, visual, sterilization and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 20360628
• Report Number: 8030965-2024-12456
• Device Sequence Number: 7199857
• Product Code: HTO
• UDI-Device Identifier: 10886982274236
• UDI-Public: (01)10886982274236(17)260630(10)26263P0
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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 Expiration Date: 06/30/2026
• Device Catalogue Number: 03.404.000S
• Device Lot Number: 26263P0
• 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: 09/27/2024
• Supplement Date Received by Manufacturer: 10/14/2024; 11/06/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 10/16/2024; 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2024
• 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 Age: 66 YR
• Patient Sex: Male