MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC 3DI CROSSCHECK MTP LEFT ORTHOLOC 3DI PLATING SYSTEM; PLATE, FIXATION, BONE

Catalog Number	5820MPX1L
Medical Device Problem Codes	Device Damaged Prior to Receipt by User (1570); Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "when we opened up the set in theatre there were 2x right mtp crosscheck plates (5820mpx1r) and no left side (5820mpx1l).There was a right sided plate in where the left should be.The patient we were doing was a left.Luckily we were able to bail out to a standard ortholoc mtp plate.This however was not the surgeons primary plan.".
Additional Manufacturer Narrative
Correction - please refer to d9, the product was not returned for investigation.The complaint couldn't be confirmed, since the device was not returned for evaluation and no other evidences were provided.Inspection of the received information/evidences are done or will be done, in the proceedings of the nc.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "when we opened up the set in theatre there were 2x right mtp crosscheck plates (5820mpx1r) and no left side (5820mpx1l).There was a right sided plate in where the left should be.The patient we were doing was a left.Luckily we were able to bail out to a standard ortholoc mtp plate.This however was not the surgeons primary plan.".

• Brand Name: 3DI CROSSCHECK MTP LEFT ORTHOLOC 3DI PLATING SYSTEM
• Common Device Name: PLATE, 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: 19780238
• Report Number: 3010667733-2024-00452
• Device Sequence Number: 18249991
• Product Code: HRS
• UDI-Device Identifier: 00840420187031
• UDI-Public: 00840420187031
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K152974
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2024

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 Catalogue Number: 5820MPX1L
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2024
• Supplement Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 07/19/2024
• Supplement Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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