MAUDE Adverse Event Report: SYNTHES GMBH 10.0MM REAMER HEAD FOR RIA 2 STERILE; ARTHROSCOPE

Model Number	03.404.016S
Medical Device Problem Codes	Break (1069); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.Additional product code: hto complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.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 (b)(6) 2023, a tibial osteotomy with im nailing procedure was conducted.A 10mm ria 2 head was used to collect graft from the tibial canal.When the surgery was almost done, it was observed that the blue ring on the back of the sterile shaft tub popped out and appeared damaged.It's almost like it melted into the metal shaft.The yellow seal was also damaged and melted into the shaft.There was a surgical delay of 3 minutes and a positive surgical outcome was attained.Plastic fragments were generated that had to be picked out of the bone graft collected.No fragments remained in the patient.Patient status/ outcome: successful this report is for one (1) 10.0mm reamer head for ria 2 sterile this is report 2 of 2 for complaint (b)(4).

• Brand Name: 10.0MM REAMER HEAD FOR RIA 2 STERILE
• Common Device Name: ARTHROSCOPE
• 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: 16460827
• Report Number: 8030965-2023-02480
• Device Sequence Number: 15065184
• Product Code: HRX
• UDI-Device Identifier: 10886982273932
• UDI-Public: (01)10886982273932
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K111437
• 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: Physician
• 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 Model Number: 03.404.016S
• Device Catalogue Number: 03.404.016S
• Device Lot Number: 78P6460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2023
• Supplement Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 04/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2020
• 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: DRIVE SHAFT FOR RIA 2 520MM; RIA 2 BONE HARVESTING KIT 520MM STERILE
• Patient Age: 60 YR
• Patient Sex: Male