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

Model Number DISSECTOR, 4.0MM X 13CM

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 12/02/2021

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

On (b)(6) 2021 it was reported by a sales representative via sems that an ar-8400ds shaver dissector broke during a rotator cuff procedure.The shaft broke at the proximal end while resecting.All pieces were recovered.It was replaced and the case was completed with no further issues.

Event Description

On (b)(6) 2021 it was reported by a sales representative via sems that an ar-8400ds shaver dissector broke during a rotator cuff procedure.The shaft broke at the proximal end while resecting.All pieces were recovered.It was replaced and the case was completed with no further issues.

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.

• Brand Name: DISSECTOR, 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: 13054567
• MDR Text Key: 286062169
• Report Number: 1220246-2021-04141
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 00888867043572
• UDI-Public: 00888867043572
• 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: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DISSECTOR, 4.0MM X 13CM
• Device Catalogue Number: AR-8400DS
• Device Lot Number: 14385309
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/02/2021
• Date Device Manufactured: 10/22/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1