MAUDE Adverse Event Report: ARTHREX, INC. MODULAR FLEXIBLE REAMER HEAD, Ø9.0MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	MODULAR FLEXIBLE REAMER HEAD, Ø9.0MM
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on (b)(6) 2023 by a sales representative via phone that an 0233-000 reamer shaft exploded (multiple pieces) while connected to the 0234-090 reamer head while drilling through the tibia.Case involvement, device broke during use.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

• Brand Name: MODULAR FLEXIBLE REAMER HEAD, Ø9.0MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 16403851
• Report Number: 1220246-2023-06312
• Device Sequence Number: 5759712
• Product Code: HSB
• UDI-Device Identifier: 00848665000856
• UDI-Public: 00848665000856
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K191598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/20/2023

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: MODULAR FLEXIBLE REAMER HEAD, Ø9.0MM
• Device Catalogue Number: 0234-090
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 02/20/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown