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

Model Number	496S275
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the evolve proline implant that read 7.5 but clearly larger than what the box says.
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
Event or Problem Description
It was reported that the evolve proline implant that read 7.5 but clearly larger than what the box says.
Additional Manufacturer Narrative
Please refer to h2, h3.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and stem diamter was found to be nonconforming to specifications.The device inspection determined the following: the stem was returned still attached to the evolve head.Attempts were made to disconnect the devices, however, they remained jammed.Digital calipers were used to measure the diamter of the stem.The stem diamter was confirmed to be 9.49mm.Based on investigation, the root cause was attributed to a manufacturing related issue.The failure was caused by an apparent mix-up during quality inspections prior to the laser marking process.A previous non-conformance has been initiated and necessary actions have been addressed in that record.
Event or Problem Description
It was reported that the evolve proline implant that read 7.5 but clearly larger than what the box says.

• 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: 15920828
• Report Number: 3010667733-2022-00429
• Device Sequence Number: 4383888
• Product Code: KWI
• UDI-Device Identifier: 00840420185877
• UDI-Public: 00840420185877
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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,Followup,Followup
• Report Date (Section B): 02/28/2023

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: 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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/07/2022
• Supplement Date Received by Manufacturer: 02/01/2023; 02/01/2023
• Initial Report FDA Received Date: 12/05/2022
• Supplement Report FDA Received Date: 02/28/2023; 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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