MAUDE Adverse Event Report: SYNTHES GMBH 12.0MM REAMER HEAD FOR RIA 2 STERILE

Model Number	03.404.020S
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Additional pro-code: hrx.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed.No conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or 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.Device was used for treatment, not diagnosis.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 unknown date while performing a ria, the surgeon noticed that he was aggressively reaming the medial cortex of the femur.He stopped 1/3 of the distance of the femur with a 12mm reamer head, and then went down to a 10mm ria head and encountered the resistance.The surgeon was concerned that he was too aggressive with the reamer size.However, we measured 14mm on the ruler and started with a 12mm.The surgeon consulted other surgeons as to whether or not he should prophylactically nail the femur.However, he decided not to since he was going to not let the patient bare weight for 3 months.It is unknown if there was a surgical delay.Procedure and patient outcome were unknown.This complaint involves two (2) devices.This report is for one (1) 12.0mm reamer head for ria 2 sterile.This is report 2 of 2 for (b)(4).

• Brand Name: 12.0MM REAMER HEAD FOR RIA 2 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: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16589788
• Report Number: 8030965-2023-03519
• Device Sequence Number: 14176367
• Product Code: HTO
• UDI-Device Identifier: 10886982273987
• UDI-Public: (01)10886982273987
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 03/21/2023

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 Model Number: 03.404.020S
• Device Catalogue Number: 03.404.020S
• Device Lot Number: 3048P28
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 03/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 10.0MM REAMER HEAD FOR RIA 2 STERILE
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 82 KG