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

Model Number 496S275

Device Problems Inadequacy of Device Shape and/or Size (1583); Component Missing (2306); Inaccurate Information (4051)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2023

Event Type  malfunction  

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.

Event 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.

Manufacturer Narrative

The complaint was confirmed, since the product was returned for evaluation and matches the alleged failure.Inspection of the received information/evidences are done or will be done, in the proceedings of the nc.If more information is provided, the case will be reassessed.

Event 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.

• Brand Name: EVOLVE STEM 7.5MM +2
• Type of Device: 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: 17347305
• MDR Text Key: 319276520
• Report Number: 3010667733-2023-00392
• Device Sequence Number: 1
• Product Code: KWI
• UDI-Device Identifier: 00840420185877
• UDI-Public: 00840420185877
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060731
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 496S275
• Device Catalogue Number: 496S275
• Device Lot Number: 1704691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Sex: Female