MAUDE Adverse Event Report: ARTHREX, INC. REAMER, LOW PROFILE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	REAMER, LOW PROFILE
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint is confirmed.The device was not returned, but a photograph was provided for evaluation.The photograph displays an unpackaged ar-1410lp with both flutes broken off.One broken flute is visible next to the device, with what appears to be bone tissue lodged in it.The second flute is not present in the photograph.Without additional information on bone quality and the angle of impact between the reamer flutes and the bone, the cause of this failure remains undetermined.A probable cause could be attributed to impacting hard bone with the drill shaft at an acute or parallel angle with the surface, as opposed to the expected normal/orthogonal angle, resulting in excessive shear forces and breaking the flutes off.
Event or Problem Description
It was reported that during a surgery the drill was being used for the first time, and at the first contact with the bone, after two seconds of usage, it got broken into two pieces.There was no harm for patient, operator or third party reported.
Additional Manufacturer Narrative
The complaint is confirmed.The device was not returned, but a photograph was provided for evaluation.The photograph displays an unpackaged ar-1410lp with both flutes broken off.One broken flute is visible next to the device, with what appears to be bone tissue lodged in it.The second flute is not present in the photograph.Without additional information on bone quality and the angle of impact between the reamer flutes and the bone, the cause of this failure remains undetermined.A probable cause could be attributed to impacting hard bone with the drill shaft at an acute or parallel angle with the surface, as opposed to the expected normal/orthogonal angle, resulting in excessive shear forces and breaking the flutes off.

• Brand Name: REAMER, LOW PROFILE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 15893332
• Report Number: 1220246-2022-05830
• Device Sequence Number: 17819483
• Product Code: LXH
• UDI-Device Identifier: 00888867016811
• UDI-Public: 00888867016811
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2022

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: REAMER, LOW PROFILE
• Device Catalogue Number: AR-1410LP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2022
• Supplement Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 12/01/2022
• Supplement Report FDA Received Date: 12/29/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown