MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline Industries, Inc.; PATEWOOD MINOR PROCEDURE

Model Number	DYNJ51729B
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility on (b)(6) 2023 during a procedure "raytec frayed and md had to pick a piece out of the patient's incision".
Additional Manufacturer Narrative
According to the facility on (b)(6) 2023 during a procedure "raytec frayed and md had to pick a piece out of the patient's incision".Per the facility the surgeon was using "adson forceps to place the raytec in the desired location".Per the facility the surgeon was able to remove the pieces from the patient.Per the facility there was no injury to the patient and no follow up care required.No additional information is available at this time.The sample is not available for evaluation.It has been determined that the reported event could cause or contribute to serious injury requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: Medline Industries, Inc.
• Common Device Name: PATEWOOD MINOR PROCEDURE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17075403
• Report Number: 1423395-2023-00027
• Device Sequence Number: 6095544
• Product Code: LRO
• UDI-Device Identifier: 10193489285161
• UDI-Public: 10193489285161
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 06/06/2023

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
• Operator of Device: Health Professional
• Device Model Number: DYNJ51729B
• Device Catalogue Number: DYNJ51729B
• Device Lot Number: 23CBD530
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2023
• Initial Report FDA Received Date: 06/06/2023
• 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 Sex: Unknown