MAUDE Adverse Event Report: WARSAW ORTHOPEDICS METRX SYSTEM; LIGHT, SURGICAL, CARRIER

Model Number 9560757

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/09/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from health care professional via manufacturing representative regarding patient with stenosis spondylolisthesis for spinal therapy.Patient demographics: gender: male; age: (b)(6).Outcome: alive no injury.Event was intra-op.Procedure used was mast tlif.Levels implanted: l4-s1 it was reported that the light source is inserted into the metrx tube per its ifu.However, after about an hour, the light source comes apart at the end.The two pieces of metal basically split in two, with one piece falling off, exposing the light.Of course the light is hot so this poses a burn risk to the patient as well as the surgical staff.It also poses a fire hazard to the patient and the or.Lastly, there is the potential for the one piece of metal that falls off to become lodged into the patient or fall into the would be unknown to the surgeon and staff.Fortunately in this case, none of these more serious issues occurred.The lights and the piece of disassociated metal were removed from the patient and discarded.No patient symptoms were reported.No further complications reported.

• Brand Name: METRX SYSTEM
• Type of Device: LIGHT, SURGICAL, CARRIER
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer (Section G): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer Contact: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 10262744
• MDR Text Key: 199721831
• Report Number: 1030489-2020-00877
• Device Sequence Number: 1
• Product Code: FSZ
• UDI-Device Identifier: 00721902663444
• UDI-Public: 00721902663444
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2024
• Device Model Number: 9560757
• Device Catalogue Number: 9560757
• Device Lot Number: 0715120W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2020
• Date Device Manufactured: 03/13/2019
• 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 Age: 35 YR