MAUDE Adverse Event Report: ARTHREX, INC. GUIDE WIRE, DOUBLE ENDED TROCAR, .86MM; ACCESSORIES, ARTHROSCOPIC

Model Number GUIDE WIRE, DOUBLE ENDED TROCAR, .86MM

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/25/2022

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

On (b)(6) 2022, it was reported by a sales representative via phone that an ar-8737-39kd guide wire had an issue during a hammertoe repair procedure.After the guide wire was inserted into the patient when the surgeon was drilling, he cut with the drill bit into the proximal portion of the guide wire and it broke inside the patient.The broken part remained in the canal of the patient's bone, and the surgeon deemed it to be safe to be left inside the patient, it was not removed.Instead of inserting a screw inside the patient's small bone canal, the surgeon decided to put a 1.6mm larger guide wire into the patient, part and lot number unknown, to complete the procedure successfully with no further impact to the patient.

• Brand Name: GUIDE WIRE, DOUBLE ENDED TROCAR, .86MM
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• 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: 15788116
• MDR Text Key: 307595971
• Report Number: 1220246-2022-05735
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00888867189706
• UDI-Public: 00888867189706
• 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: 11/14/2022

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: GUIDE WIRE, DOUBLE ENDED TROCAR, .86MM
• Device Catalogue Number: AR-8737-39KD
• Device Lot Number: 2199123527
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/25/2022
• Initial Date FDA Received: 11/14/2022
• Date Device Manufactured: 08/18/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1