MAUDE Adverse Event Report: ARTHREX, INC. DISSECTOR, CURVED 4.0MM X 13CM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number DISSECTOR, CURVED 4.0MM X 13CM

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/01/2022

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 on (b)(6) 2022 by a sales representative via sems that an ar-8400cds dissector caused metal shavings when used.Case involvement, device broke during use, fragments unable to be removed.

• Brand Name: DISSECTOR, CURVED 4.0MM X 13CM
• 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: 15959686
• MDR Text Key: 306957141
• Report Number: 1220246-2022-05939
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 10888867043494
• UDI-Public: 00888867043497
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DISSECTOR, CURVED 4.0MM X 13CM
• Device Catalogue Number: AR-8400CDS
• Device Lot Number: 14976906
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/01/2022
• Date Device Manufactured: 07/01/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1