MAUDE Adverse Event Report: ARTHREX, INC. MINIMALLY INVASIVE HARVESTER, CLOSED; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	MINIMALLY INVASIVE HARVESTER, CLOSED
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2021
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 an internal right and semitendinosus surgery the welding of the end of the device has released.The cutting part detached from the handle inside the patient making it impossible to remove the graft with this instrument.The broken off piece was retrieved from the patient.According to the surgeon there was no harm for patient, operator or third party.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.
Additional Manufacturer Narrative
Complaint confirmed, the tip detached due to the weld breaking.Laser markings are discolored.No further damage observed.The device was manufactured in 2015.The cause of the event is undetermined.

• Brand Name: MINIMALLY INVASIVE HARVESTER, CLOSED
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11841593
• Report Number: 1220246-2021-03096
• Device Sequence Number: 19955923
• Product Code: MDM
• UDI-Device Identifier: 00888867006942
• UDI-Public: 00888867006942
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2021

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: MINIMALLY INVASIVE HARVESTER, CLOSED
• Device Catalogue Number: AR-1279L
• Device Lot Number: 4461505
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/26/2021
• Supplement Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 09/08/2021
• Patient Sequence Number: 1