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

Model Number MMSN2014

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/06/2022

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 308524721
• Report Number: 1417592-2023-00036
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10193489120417
• UDI-Public: 10193489120417
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: MMSN2014
• Device Catalogue Number: MMSN2014
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/07/2022
• Initial Date FDA Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: R-22-199
• Patient Sequence Number: 1
• Patient Outcome(s): Other