MAUDE Adverse Event Report: SYNTHES GMBH 12.5MM REAMER HEAD FOR RIA 2 STERILE

Catalog Number	03.404.021S
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
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.H11 additional manufacturer narrative: h3, h6: manufacturing location: supplier ¿ (b)(4) / inspected and packaged by: monument.Release to warehouse date: 01-05-2024.Expiration date: 30-nov-2033.Part number: 03.404.021s, 12.5mm reamer head for ria 2-sterile.Lot number: 8990p99 (sterile).A manufacturing record evaluation was performed for the finished device with batch number 8990p99.No nonconformities or manufacturing irregularities have identified related to the complaint condition.The product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that '03.404.021s, reamer head f/ria 2 ø12.5¿ had broken.However, the reported condition of embedded device remains unconfirmed.The observed condition of the device was consistent with a component failure that may have been caused by exposure to unintended forces.The allegation of embedded device can not be confirmed as no patient x-rays were provided to evaluate the condition.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the reamer head f/ria 2 ø12.5 would contribute to the complained device issue.Based on the investigation findings, potential cause can be attributed 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 depuy synthes 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.
Event or Problem Description
It was reported that while doing a ria2 case the reamer broke and left fragments in a patients femur.Surgeon was able to remove a majority of the instrument by pulling the ball tip guide wire out but some fragments of it were unable to be removed.

• Brand Name: 12.5MM REAMER HEAD FOR RIA 2 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: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 23714901
• Report Number: 8030965-2025-12135
• Device Sequence Number: 8982112
• Product Code: HTO
• UDI-Device Identifier: 10886982274007
• UDI-Public: (01)10886982274007(17)331130(10)8990P99
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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

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: 03.404.021S
• Device Lot Number: 8990P99
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2024
• 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