MAUDE Adverse Event Report: ARTHREX, INC. DISPS KIT,TRANS-TIB ACL W/ SAWBLD; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number DISPS KIT,TRANS-TIB ACL W/ SAWBLD

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/16/2019

Event Type  Injury  

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 Description

It was reported that after an acl case, an x-ray showed that about 3 inches of the guidewire in the ar-1897s kit remained in the patient.Same day, they went back into the patient and removed it.Patient is male, (b)(6); he did not require any additional hospitalization.

• Brand Name: DISPS KIT,TRANS-TIB ACL W/ SAWBLD
• 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: 9756018
• MDR Text Key: 190136011
• Report Number: 1220246-2020-01720
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 00888867022454
• UDI-Public: 00888867022454
• 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: health professional,user faci
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DISPS KIT,TRANS-TIB ACL W/ SAWBLD
• Device Catalogue Number: AR-1897S
• Device Lot Number: 10440466
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/10/2020
• Date Device Manufactured: 11/05/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other