MAUDE Adverse Event Report: ARTHREX, INC. TISSUE ELEVATOR, 15 DEG UP, STANDARD; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	TISSUE ELEVATOR, 15 DEG UP, STANDARD
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2022
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
Knee scorpions stopped working and 1 x elevator broke during a procedure.The procedure was completed using another knee scorpion and elevator.No patient harm.

• Brand Name: TISSUE ELEVATOR, 15 DEG UP, STANDARD
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• 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: 15093824
• Report Number: 1220246-2022-05305
• Device Sequence Number: 5174689
• Product Code: MDM
• UDI-Device Identifier: 00888867013346
• UDI-Public: 00888867013346
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 07/25/2022

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: TISSUE ELEVATOR, 15 DEG UP, STANDARD
• Device Catalogue Number: AR-1344SE-15
• Device Lot Number: 011734
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2022
• Initial Report FDA Received Date: 07/25/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown