MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE UNITE; SCREW, POLYAX LOCKING, MINI, 2.4 X 12MM

Model Number	MFSL2412
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2023, when inserting the screw to correct a "metatarsal fracture" the "screw head broke off" while being tightened into the plate.The customer reported they attempted to remove the screw with a "mini shukla" but, were unsuccessful and the "threads" were left inside the patient.The customer reported the procedure took "a detour" due to the attempt to remove the screw but, the procedure was completed using the "mini plating tray".According to the customer there was no serious injury identified, follow up care needed, or medical intervention required related to the reported incident.No additional information is available at this time.The sample is not available for return evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.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.
Event or Problem Description
According to the customer, on (b)(6) 2023, when inserting the screw to correct a "metatarsal fracture" the "screw head broke off" while being tightened into the plate.

• Brand Name: MEDLINE UNITE
• Common Device Name: SCREW, POLYAX LOCKING, MINI, 2.4 X 12MM
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17308285
• Report Number: 1417592-2023-00285
• Device Sequence Number: 6506284
• Product Code: HWC
• UDI-Device Identifier: 10888277690288
• UDI-Public: 10888277690288
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 07/12/2023

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: MFSL2412
• Device Catalogue Number: MFSL2412
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 07/12/2023
• 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