MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline; SCREW,NON-LOCKING,MINI T8,2.0 X 14MM

Model Number	MMSN2014
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, when performing a "distal bunion" procedure on (b)(6) 2022 the "screw broke right under the head and the threads had to be removed." the customer reported the implant was removed and the patient is doing "fine".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.Sample not available to be returned.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, when performing a "distal bunion" procedure on (b)(6) 2022 the "screw broke right under the head and the threads had to be removed.".

• Brand Name: Medline
• Common Device Name: SCREW,NON-LOCKING,MINI T8,2.0 X 14MM
• 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: 16274523
• Report Number: 1417592-2023-00036
• Device Sequence Number: 14950305
• Product Code: HWC
• UDI-Device Identifier: 10193489120417
• UDI-Public: 10193489120417
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 12/07/2022

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: MMSN2014
• Device Catalogue Number: MMSN2014
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2022
• Initial Report FDA Received Date: 01/31/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: R-22-199
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown