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

Model Number	9560757
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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
• Common Device Name: LIGHT, SURGICAL, CARRIER
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 10262744
• Report Number: 1030489-2020-00877
• Device Sequence Number: 14318427
• Product Code: FSZ
• UDI-Device Identifier: 00721902663444
• UDI-Public: 00721902663444
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K993021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/13/2020

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2020
• Initial Report FDA Received Date: 07/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR