MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC TI LOCK SCREW 2.4 X 12MM ORTHOLOC SYSTEM STERILE; SCREW, FIXATION, BONE

Model Number	520S024012
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during insertion of the third screw into a plate that the screw broke when halfway inserted.The broken screw was left inside the body and the fixation was completed because it could not be removed.
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.

• Brand Name: TI LOCK SCREW 2.4 X 12MM ORTHOLOC SYSTEM STERILE
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16574417
• Report Number: 3010667733-2023-00131
• Device Sequence Number: 6117308
• Product Code: HWC
• UDI-Device Identifier: 00840420145024
• UDI-Public: 00840420145024
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K090692
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 520S024012
• Device Catalogue Number: 520S024012
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 03/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown