MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC MICA FIRST MET TRANSLATOR STERILE MICA; GAUGE, DEPTH

Model Number	57S100MT
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The translator was broken while trying to translate the osteotomy site during a great toe bunion surgery.Other instrumentation was used to translate the met head laterally.
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
The translator was broken while trying to translate the osteotomy site during a great toe bunion surgery.Other instrumentation was used to translate the met head laterally.
Additional Manufacturer Narrative
Correction g8: this report should have been reported under fda registration number (b)(4) h5, h8.The reported event could be confirmed since an image was provided and matches the alleged failure mode.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The current instructions for use states: "surgical instruments and instrument cases are susceptible to damage from prolonged use, and through misuse or rough handling.Care must be taken to avoid compromising their exacting performance." a review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: MICA FIRST MET TRANSLATOR STERILE MICA
• Common Device Name: GAUGE, DEPTH
• 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: 15260433
• Report Number: 0001043534-2022-00003
• Device Sequence Number: 20505096
• Product Code: HTJ
• UDI-Device Identifier: 00889797071994
• UDI-Public: 00889797071994
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2022

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: 57S100MT
• Device Catalogue Number: 57S100MT
• Device Lot Number: 2486028
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2022
• Supplement Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 08/19/2022
• Supplement Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2021
• 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 Age: 55 YR
• Patient Sex: Female
• Patient Weight: 73 KG