MAUDE Adverse Event Report: ARTHREX, INC. HANDLE, REPLACEMENT, SUCTION DOWNBITER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	HANDLE, REPLACEMENT, SUCTION DOWNBITER
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2021
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
It was reported that during a knee surgery a piece of metal chipped off from the tip of the device.All broken off pieces were retrieved from the patient.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.Update 29-oct-2021: the product was updated as the actual affected device is the ar-6701-48.

• Brand Name: HANDLE, REPLACEMENT, SUCTION DOWNBITER
• 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: 12819186
• Report Number: 1220246-2021-03946
• Device Sequence Number: 11210744
• Product Code: LXH
• UDI-Device Identifier: 00888867040786
• UDI-Public: 00888867040786
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 11/16/2021

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
• Device Model Number: HANDLE, REPLACEMENT, SUCTION DOWNBITER
• Device Catalogue Number: AR-6701-48
• Device Lot Number: 2055080309
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 11/16/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown