MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC EVOLVE STEM 7.5MM +2; PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Catalog Number	496S275
Medical Device Problem Codes	Component Missing (2306); Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint could be confirmed, since the information for evaluation matches the alleged failure.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.H3 other text : device disposition unknown.
Event or Problem Description
It was reported that the patient presented for a primary surgery to treat a radial head fracture.During the procedure it was noted that the radial stem was mislabeled.The box said 7.5mm + 2 but it was much larger.The physician substituted head/stem sizes.There was a surgical delay of 5 minutes.The patient was unaffected due to this and the procedure was completed successfully.

• Brand Name: EVOLVE STEM 7.5MM +2
• 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: 17627912
• Report Number: 3010667733-2023-00484
• Device Sequence Number: 6118476
• Product Code: KWI
• UDI-Device Identifier: 00840420185877
• UDI-Public: 00840420185877
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K060731
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/25/2023

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: Lay User/Patient
• Device Catalogue Number: 496S275
• Device Lot Number: 1704691
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2021
• 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 Sex: Unknown