MAUDE Adverse Event Report: ARTHREX, INC. DISSECTOR, 5.0MM X 13CM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number	DISSECTOR, 5.0MM X 13CM
Health Effect - Clinical Code	Insufficient Information (4580)
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.
Event or Problem Description
It was reported that two devices from the same lot (11982055) produced metal abrasion during a knee surgery.According to the nurse no harm for patient, operator or third party occurred.The knee surgery was finished successfully with the same devices.It was not necessary to switch the surgical technique or do a second surgery.Update (b)(6) 2021: it was confirmed that the metal abrasion occurred inside the patient and all fragments were retrieved from the patient.The surgery was finished successfully with a new device with the same part number but different lot number.The two affected devices were discarded by the facility and the remaining devices of the package plus an additional package of the affected lot will be returned.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-8500ds (no batch number present) was received for investigation, in addition to two packages containing five sealed ar-8500ds, batch 11982055 devices each.Both the complaint device and a freshly unsealed ar-8500ds were compared under micro-vu id: 654, where it was observed that the complaint dissector had circumferential grooves present inferior to the inner tube collar, as well as slight wear along the inner diameter of the outer tube hood.The new device did not display the same abnormalities.Overall, no problems were found with the new sample.The signs of debris production present on the complaint device were consistent with user applied mechanical forces via prying/leveraging the device against bone and/or hard tissue.

• Brand Name: DISSECTOR, 5.0MM X 13CM
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11647652
• Report Number: 1220246-2021-02873
• Device Sequence Number: 3832887
• Product Code: GFA
• UDI-Device Identifier: 00888867043794
• UDI-Public: 00888867043794
• 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,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Model Number: DISSECTOR, 5.0MM X 13CM
• Device Catalogue Number: AR-8500DS
• Device Lot Number: 11982055
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/21/2021
• Supplement Date Received by Manufacturer: 03/21/2021
• Initial Report FDA Received Date: 04/12/2021
• Supplement Report FDA Received Date: 06/22/2021
• Patient Sequence Number: 1