MAUDE Adverse Event Report: ARTHREX, INC. DISSECTOR, SJ 3.0MM X 7CM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number DISSECTOR, SJ 3.0MM X 7CM

Device Problem Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/13/2021

Event Type  malfunction  

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 Description

It was reported that during an arthroscopic surgery metal debris was identified.There was no harm for patient, operator or third party reported.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.On 03-aug-21 update: further information were provided that the debris was flushed out of the patient and nothing remained in the patient.

• Brand Name: DISSECTOR, SJ 3.0MM X 7CM
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• 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: 12361283
• MDR Text Key: 269600761
• Report Number: 1220246-2021-03540
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 00888867041943
• UDI-Public: 00888867041943
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/24/2021

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 Operator: Health Professional
• Device Model Number: DISSECTOR, SJ 3.0MM X 7CM
• Device Catalogue Number: AR-7300DS
• Device Lot Number: 12213364
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2021
• Initial Date FDA Received: 08/24/2021
• Date Device Manufactured: 12/01/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1