MAUDE Adverse Event Report: SYNTHES GMBH DRIVE SHAFT FOR RIA 2 520MM; REAMER

Catalog Number	03.404.035
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Embolism/Embolus (4438)
Date of Event	11/14/2025
Type of Reportable Event	Serious Injury
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.Additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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 the drain tree became fused with the tubing and burr during the reaming of the canal, and the tubing ruptured inside it.At the start of the surgery, the tubing leaked, with water escaping.The patient went into cardiac arrest, and removing the drain tree proved too complex, requiring a larger surgical approach and a femoral osteotomy.
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: 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch 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: added: a2 (age), b5, h6 (health effect - clinical code).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: a 43-year-old patient with a 16-year history of chronic osteomyelitis of the right femur was hospitalized on (b)(6) 2025, due to pain and a non-active fistula; at the time of the procedure, the patient was in good condition but had poor pain control, with a fistula showing reluctance, flushing, edema, and erythema, without fever or other symptoms.The surgical plan was to wash the right intramedullary canal; however, during assembly of the ria 2 system, a saline leak occurred.Milling was initiated using synream and manual cutters, followed by passage of the ria with a 15 mm milling head.During reaming, the ria hose became blocked, and the patient suffered cardiac arrest requiring cardiopulmonary resuscitation.Due to inability to remove the trapped hose, an urgent subtrochanteric osteotomy was performed.Post-procedure review revealed the shaft fused with the hose.The patient was placed on ecmo and transferred to the icu, later referred to (b)(6).Ecmo was discontinued after three days; brain mri revealed cerebral embolism, and the patient subsequently died at (b)(6).

• Brand Name: DRIVE SHAFT FOR RIA 2 520MM
• 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: 23729850
• Report Number: 8030965-2025-12219
• Device Sequence Number: 21269946
• Product Code: HTO
• UDI-Device Identifier: 10886982274243
• UDI-Public: (01)10886982274243
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Distributor
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.404.035
• 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: 11/17/2025
• Supplement Date Received by Manufacturer: 12/11/2025; 12/26/2025
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 12/22/2025; 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR
• Patient Sex: Female