MAUDE Adverse Event Report: ARTHREX, INC. FLEXIBLE REAMER SHAFT, 2.0MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	FLEXIBLE REAMER SHAFT, Ø2.0MM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2021
Type of Reportable Event	Malfunction
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.
Event or Problem Description
On (b)(6) 2021, it was reported by a sales representative via e-mail that the 0222-200 was found defective and unusable.No case involvement.Additional information provided 8/27/2021: started flex reamer from aos humeral nail set at 6.5mm through a 10.5mm entry hole down the humeral canal.Surgeon immediately noticed a ¿chatter¿ sound which then sized up reamers by.5mm until they reached 8.Throughout upsized reaming, surgeon noticed the same ¿chatter" sound.Halfway down humeral canal, flex reamer broke and revealed a faulty flex reamer base which had separated from the flex shaft leaving ao connect in drill hand piece.The case was completed by using an aos tibia/femoral flex reamers set.

• Brand Name: FLEXIBLE REAMER SHAFT, 2.0MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12467672
• Report Number: 1220246-2021-03650
• Device Sequence Number: 3907807
• Product Code: LXH
• UDI-Device Identifier: 00848665023688
• UDI-Public: 00848665023688
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 09/14/2021

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: FLEXIBLE REAMER SHAFT, Ø2.0MM
• Device Catalogue Number: 0222-200
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 09/14/2021
• Patient Sequence Number: 1