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

Model Number	03.404.016S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2023, the surgeon was attempting to use the ria through a non union site.The splines on the 10mm reamer had broke, leaving several fragments in the canal of the femur.The surgeon worked to ensure he removed all of the fragments from the reamer head.The surgeon then made an antibiotic nail using a 3.0 reaming rod, cement and temporarily implanted it in the femur.There was 20 min surgical delay.Procedure was completed successfully.There was no patient consequences.Concomitant device reported: unk - nails(part# unknown, lot# unknown, quantity: unknown).Unk - reaming rods: trauma(part# unknown, lot# unknown, quantity: unknown).Unk - biomaterial - cement(part# unknown, lot# unknown, quantity: unknown).This report is for one (1) 10.0mm reamer head for ria 2 sterile.This is report 1 of 1 for complaint (b)(4).This complaint involves one(1) device.
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.Additional product code: hto.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h6: 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.

• 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: 17042250
• Report Number: 8030965-2023-06970
• Device Sequence Number: 8739495
• Product Code: HRX
• UDI-Device Identifier: 10886982273932
• UDI-Public: (01)10886982273932
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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

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: 795P870
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2022
• 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: 3.0 REAMING ROD/950 STR BALL TIP - SILE.; UNK - BIOMATERIAL - CEMENT.; UNK - NAILS.
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Weight: 45 KG