MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP PENDING; GUIDEWIRE,NON-THREADED,0.9 X 150MM

Model Number	MSG09150
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Guidewire broke in two pieces during procedure.
Additional Manufacturer Narrative
The customer reported "intraoperatively, surgeon was using 0.9mm guide wire during the procedure and the guide wire broke into two pieces.Both pieces were retrieved, and the length were compared against another similar piece.Or manager was informed.The broken guide wire was taken out of the sterile field and labeled and given to or manager".No additional information was provided by the customer despite multiple good faith efforts.A sample was requested to be returned for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: PENDING
• Common Device Name: GUIDEWIRE,NON-THREADED,0.9 X 150MM
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17210284
• Report Number: 1417592-2023-00266
• Device Sequence Number: 6798312
• Product Code: LXH
• UDI-Device Identifier: 10888277139695
• UDI-Public: 10888277139695
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: MSG09150
• Device Catalogue Number: MSG09150
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2023
• Initial Report FDA Received Date: 06/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 35 YR
• Patient Sex: Female