MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC EVOLVE HEAD 22MM; PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Model Number	496H022
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Component Missing (2306); Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
According to the report, a packing error was identified whereby an incorrect implant size was erroneously packaged with labeling inconsistent with its actual size.As a consequence, a surgical delay of approximately 15-20 minutes occurred.
Additional Manufacturer Narrative
Device is not available for evaluation as it remains implanted in the patient.If additional information becomes available, it will be provided on a supplemental report.Device remains implanted in the patient.
Event or Problem Description
According to the report, a packing error was identified whereby an incorrect implant size was erroneously packaged with labeling inconsistent with its actual size.As a consequence, a surgical delay of approximately 15-20 minutes occurred.
Additional Manufacturer Narrative
Please note the corrections made to the d9/h3, h3, h6 (device & component code): the complaint could was not confirmed, indeed the product was returned for evaluation, but it does not matches the alleged failure.The device inspection revealed the following: visual examination of the received products shows that the returned parts (stem and head) are mounted together.Furthermore, the parts show no visual damage.Furthermore, the stem turned out to be the problem here because it was manufactured incorrectly, for more information see other pr.Quality assurance engineering reviewed the received information and noted: i checked the diameter, and it is within spec, as the part is united with the other part, i cannot take it out to check any other dimension.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.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.If more information is provided, the case will be reassessed.

• Brand Name: EVOLVE HEAD 22MM
• Common Device Name: PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
• 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: 17347306
• Report Number: 3010667733-2023-00391
• Device Sequence Number: 14962863
• Product Code: KWI
• UDI-Device Identifier: 00840420126061
• UDI-Public: 00840420126061
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K991915
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2023

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
• Device Model Number: 496H022
• Device Catalogue Number: 496H022
• Device Lot Number: 1740515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2023
• Supplement Date Received by Manufacturer: 09/13/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2023
• 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: 43 YR
• Patient Sex: Female